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February 16, 2024

Root Cause Analysis with example for “5” Why technique

Root Cause Analysis (RCA) is a method that is used to address a problem or non-conformance in the quality process to get to the “root cause” (actual cause of origin) of the non-conformity. RCA helps to correct or eliminate the cause and prevent the problem from recurring (preventive action). Root cause analyses is aimed at improving products or processes quality and must an in systematic ways to be effective. Different Methods of doing Root Cause Analysis: Root Cause Analysis Methodology   Fish bone technique The “5” Why’s technique. Barrier Analysis Change Analysis Casual Factor tree analysis Failure mode and effects analysis Pareto analysis Advantages: To identify non-conformity and the causes, so that permanent solution can be found. To develop a logical approach of problem-solving, using data that already exists in QMS (Quality Management System) To identify current and also future needs for organizational quality improvement. To establish a repeatable systematic step by step processes, in which one process can confirm the results of another with deep analysis. Challenges: Not having the ability to understand the problem and therefore not defining it correctly. Not considering all possible failure modes. Not able to identify all root causes. No proper defined solution for the non-conformity. The “5” Why technique causes mapping Non-conformity identified: Decrease in the viscosity of Vitamin D3 syrup. The “5” why technique can be expanded to 15 why or 150 why the deeper you go the more thorough analyzing takes place and reveals better solutions Contact us for more information about the AmpleLogic Quality Systems Offerings.   Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom (UK)United States (US)United States (US) Minor Outlying IslandsUnited States (US) Virgin IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabweWhere you heard about us?– Select –Google SearchLinkedInReferralWord of MouthLinkedIn AdsMediumRequirementGet in touch

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February 6, 2024

Why is embracing the Document Management System still intimidating?

DMS in a layperson perception A thorough-cum-simpler explanation of Document Management System will make us understand about the efficacy of this digital trend. With the name “Electronic Document Management System”, we get an overall idea that the system is supposedly managing the documentation process. Now, this process is the common one being done in every organization, we all know. Here the point comes is : How are these documentation things being processed or managed in various industries these days? Collecting all the needed data or information of a company and putting them down in a specific file or document is something that we know very well, which has been done manually for ages. But with trending technological inventions like IoT, AI, Cyber Security, etc., in the ongoing digital world, we must step up to a more effort-less mode of documentation. So, with this, we came up with eDMS.  Replacing manual documentation work to automated-cum-electronic documentation, Electronic Document Management System has brought a different level of changes in contemporary pharma as well as life sciences companies. A quick peek of digitalization using Electronic Document Management Software (eDMS) While DMS has given us chances to ease our pain with an effective modification in documentation tasks, FDA’s 21 CFR part 11 has confirmed that electronic documents along with the records and signatures can surely be considered as the legitimate ones. Hence, it has confirmed that there will be no difference between paper signature and e-signature, rather the later one will be more considerable. Let’s have a quick walk through the benefits we have gained with Electronic Document Management System in contemporary pharma companies. Easy creation, management, and storage of all the crucial data and information of the company is possible with DMS. On incorrect data feeding, mismatch of information, missing data, you will get a reminder or notification which is not possible in manual management. All the data is stored in a specific and common cloud, which is accessible to everyone from everywhere. A smooth documentation now ensures a streamline workflow and saves a lot of time and resources which can be used in other areas of growth. Complete replacement of paperworks into paperless documentation becomes easy with eDMS. Having thorough data on drugs, research, new compliances, regulations require error-free documentation and with Pharmaceutical Document Management Solution this task can be managed easily. Storage of all the digital documents under a common cloud is much safer than keeping manual data in the form of documents stored in some physical storage. Accessible cloud storage documentation allows you to access the data whenever and wherever required, whereas in manual management there is some chance of missing out on important data. An organized documentation not only takes care of the data storage but also ensures a smooth flow of additional departments like SOP Management, manufacturing, operation, quality planning, etc. Terrorizing reasons restricting full-fledged eDMS inculcation Despite a lot of benefits, there are many companies who are reconsidering their decisions of incorporating Document Management Systems into their business. Every innovation comes with certain pros and cons. When we have already understood several benefits of the automatic documentation process, let’s explore the risky or stressed side or probable challenges of this digital trend. Data being vulnerable: With documentation being staged on digital platforms, it is extremely necessary to keep an eye on the security side. When crucial data is stored in the cloud then there comes a major terror of data being vulnerable and being attacked by malicious cyber frauds. Hence, it is required to maintain utmost cybersecurity ensuring the documentation is safe in the cloud kept away from cyber thefts. Doubt on successful implementation: There are so many growing features of Electronic Document Management and Tracking Software for Lifesciences industries, but we need to explore all those specifications accurately. Adding on a digital trend to a business could sound fun, but the real game starts when you implement the software effectively. This can be done with active seminars, group discussions, and taking feedback from employees (who are using it) on document management solution. Fear of smooth integration: The DMS must come up with appropriate integration of all relevant departments, then only we can assure its potential usage. Hence integration of DMS with other in-house applications must be done properly to make the system work automatically and independently. Staying inconsistent in usage: To replace paperworks with digital paperless ones, giving employees detailed training on Pharmaceutical Document Management and Tracking Software is essential. Hence, keeping the usage of DMS consistent becomes a tough task if the users are not well-trained. So, the prior task is to train employees about the usage of the platform and bring consistency in keeping the system in work consistently. Realising the probable challenges as well as conquered benefits of Document Management Solution we can easily understand how to proceed with this amazing transformation from loads of paper-based documents to hassle-free paperless one-stop-data centres. AmpleLogic’s best DMS software is assisting several pharma as well as other businesses to successfully implement this amazing digital tweak to their work processes making lives easier. Talk to our team to enroll for a free demo on Electronic Document Management System. Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom (UK)United States (US)United States (US) Minor Outlying IslandsUnited States (US) Virgin IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabweWhere you heard about us?– Select –Google

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February 6, 2024

Benefits of Training Management System

Here’s what a Training Management System can, and should, do for you: Learning Management System makes it very easy for trainers to update existing training content or add new content in a short time Comply and Meet essential regulatory requirements and other best practices more easily Enhance managers and employees ability to achieve required results, not just complete the training Measure the reduction in operational expenses, travel time and on-site visits Reduce the time for needed for creating, updating, printing and shipping of learning course manuals and documentation Dramatically reduce the cost of software for managing and creating training courses Improve the administration of your learning programs Increase your ability to manage and deploy e-learning to your employees across any location Consolidates training information to improve efficiency, improved facilities coordination and cost utilization Improve personnel performance by enabling you to manage admiration and human resources more effectively Implement more and more effective skills and competency training management programs Reduce training costs Increase the number of training courses that you can deliver for less money Training Course materials on an effectively deployed Learning Management System (LMS) can be accessed by employees across geographies, without affecting the quality or consistency of training These training systems allow the creation, personalization, and download of detailed training reports outlining the progress of the learners, departmental groups, completion of work, time taken to complete the task, etc. which allows easy evaluation of their progress either as an individual or a group A modern Learning Management System, like AmpleLogic LMS, can support your organizations as it grows, and give you the flexibility to add the latest features and functionality to support your training and learning programs Are you ready to invest in a new Learning Management System or LMS? Contact us today to find out more or schedule a demo. Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom (UK)United States (US)United States (US) Minor Outlying IslandsUnited States (US) Virgin IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabweWhere you heard about us?– Select –Google SearchLinkedInReferralWord of MouthLinkedIn AdsMediumRequirementGet in touch

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February 6, 2024

GAMP 5 Categories, V Model and 21 CFR Part 11, EU Annex 11

What is GAMP 5? Good Automated Manufacturing Practice, Founded in 1991. International Society for Pharmaceutical Engineering (ISPE) sets the guidelines for manufacturers and the current Version is GAMP 5. GAMP describes a set of principles and procedures that help ensure that pharmaceutical Software (Like QMS Software, LMS software, DMS software etc.) has required quality. Computer system validation (CSV) following GAMP guidelines require users and suppliers to work together so that responsibilities regarding the validation process are understood. For users: GAMP provides a documented assurance that a system is appropriate for the intended use before it goes “live.” Suppliers can use GAMP to test for avoidable defects in the supplied system to ensure quality products are produced. Why GAMP 5? Facilitates the interpretation of regulatory requirements. Establishes a common language and terminology. Promotes a system life cycle approach based on good practice. Clarifies roles and responsibilities. Focus attention on those computerized systems with the most impact on patient safety, product quality, and data integrity Avoid duplication of activities There are five key concepts to GAMP 5: Product and Process Understanding Lifecycle approach within QMS Scalable Lifecycle Activities Science Based Quality Risk Management Leveraging Supplier Involvement GAMP 5 Categories Difference between Category 4 and Category 5 in GAMP 5 Configuration and customization of software are terms that are poorly defined in the validation world and frequently used interchangeably, especially in a vendor’s marketing literature. It is important to understand the difference between these two terms as they mean entirely different things and consequently can have a dramatic impact on the amount of validation work that you could undertake. Configuration: The modification of the function of a software product to meet the business process or user requirements using tools supplied by the supplier. These tools can include the input of user-defined text strings for drop-down menus, turning software functions on or off, graphical dragging and dropping of information elements, and creation of specific reports using the standard functionality of the package. Customization: The writing of software modules, scripts, procedures, or applications to meet business requirements. This can be achieved using an external programming language (such as C++ or .NET or PL*SQL for database procedures), macro instructions, or an internal scripting language specific for a commercial application. Depending on the user requirements the same implementation can be Category 4 or 5 What is SDLC Model?  What model GAMP 5 Suggests? The software development life cycle (SDLC) is a framework defining tasks performed at each step in the software development process. SDLC is a structure followed by a development team within the software organization. It consists of a detailed plan describing how to develop, maintain and replace specific software. The life cycle defines a methodology to deliver the quality of software and the overall development process. What is 21 CFR Part 11 and EU Annex 11? 21 CFR (Code of Federal Regulations) Part 11 has defined by the US FDA regulations that set forth the criteria applies to electronic records and electronic signatures that persons create, modify, maintain, archive, retrieve, or transmit under any records or signature requirement set forth in the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, or any FDA regulation Annex 11 is part of the European GMP Guidelines and defines the terms of reference for computerized systems software used by organizations in the pharmaceutical industry. Queries? Any relation between GAMP 5 or v Model with 21 CFR Part 11? Both are the set of guidelines which are used to validate a computer-based software used in pharma manufacturing companies. The guidelines are predefined, and software should comply with the guidelines. GAMP talks about “the How” and the 21 CFR talks “the What” during the Validation of computer-based software for Pharma companies. GAMP is a methodology and 21 CFR are a regulation 21 CFR Part 11 is US FDA and Annex 11 is EU guidelines. A Company is delivering software to the banking sector they never heard of part 11 but when the Pharma customer wants them to map Part 11 requirements will the solution comply with them? Even if a company is delivering software to the banking sector, the solution will generally comply with part 11 requirements. In banking software’s there may not be the reference of Part 11, but the requirements of Part 11 will be met by the banking software’s A software company is following SDLC models from the past 8 years. For the first time, they are delivering a pharma software solution. When the customer team comes for an audit what software development methodologies they need to demonstrate to win the auditor. Whenever there is an audit of the customer need to explain the detailed procedure followed to develop software right from the beginning of User requirement gathering to the maintenance and support. Even if the company does not know the standard guidelines, we can map the existing followed procedure with the guidelines and standards to comply with client requirements. The company which comes to audit have a set of guidelines or criteria which the supplier should comply to pass the audit. The pharma companies investigate whether the software follows GAMP, or Part 11 or EU annexure 11. To win the auditor the company must have followed an SDLC Methodology with Proper Reviews and Tracking. A software company doesn’t want to follow the V model, still wanted to deliver pharma software (Quality Management Software, Document Management System, ANDA and DMF tracker etc.). Will this be acceptable to Pharma Company? Acceptable if Software Company follows standard SDLC models and follows the Standards for developing and managing the code. Explore Our GMP Solutions eQMS DMS LMS RIMS QC Planning eLogbook LIMS APQR Asset Management EMS eBMR UMS View All Solutions Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard

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AI
February 6, 2024

Integration of Artificial Intelligence and Machine Learning in QMS

  Integration of AI & ML in Quality Management Systems There is no doubt that we have entered the new industrial revolution, commonly referred to as Industry 4.0. Digitalization is transforming the way products are being manufactured, controlled, distributed and improved upon. For years though, pharmaceutical companies were lagging behind due to the high cost of process shifting imposed by stringent GMP compliance requirements by US FDA and MHRA, lengthy software implementation timelines and high validation cost . Reasonably so, as caution is necessary before adopting any new technology in such a delicate field. However, the pandemic has forced the entire Pharma industry to kick up a gear. Rapid increase in demand especially for biopharmaceutical products and medical devices over the past couple of years revealed inabilities of traditional setups to adapt to sudden changes in market requirements. Today organizations are spending a good amount of money on process deviations. An average cost of deviation (start to end) will cost nearly USD 40000 to 200000 per deviation. There are certain steps in deviations that can be digitalized with the AI/ML technologies, resulting in reduced cost of deviations by 60%. As a result, pharmaceutical industry has been propelled into Pharma 4.0, fueled by sophisticated technological solutions that significantly improve efficiency of an average manufacturing unit. How Artificial Intelligence and Machine Learning can be Integrated into Quality Management A typical pharmaceutical plant collects a remarkable amount of data as part of the quality assurance process. By having to document every part of the process to ensure quality tracking and error traceability, even a mid-sized manufacturing facility’s QMS software will collect enough data in one year to overwhelm an average server. Traditional means of storing data on local servers quickly become cumbersome, expensive and difficult to manage, as they require almost constant investments into equipment maintenance and capacity increases. Storing all the information is only part of the problem, solvable by relying on cloud services. An even bigger issue lies in the inefficiency of such a practice. Mountains of data remain unanalyzed, unused and practically forgotten. The only purpose becomes compliance, missing out on valuable opportunities to spot mistakes as they happen and gather valuable insight through in-depth analysis. The amount of stored data only continues to grow with every new device and process being introduced into the system. Unless indexed and stored in such a way to allow effective analysis, both in real time and retroactively, it is essentially wasted. Modern technology aims to solve this problem and offer opportunity for continuous improvement. Big data, artificial intelligence (AI), machine learning (ML) and deep learning (DL) are tools that turn these mountains of unusable pieces of information into valuable pools of data, insights and predictions. Data is practically useless – knowledge is what is valuable. These tools do exactly that: turn data into knowledge. The traditional means of identifying, reporting and fixing problems are highly inefficient compared to possibilities offered by AI. 21 CFR (part 11) states that every pharmaceutical manufacturer is obliged to establish procedures to implement corrective and preventive action in case of errors (the CAPA system). In other words, to identify the underlying cause of the detected issue, resolve it and prevent it from happening again, as well as to avoid such problems in the first place. The usual way of handling errors is to manually maintain the CAPA register, monitor and track the actions taken, all the while relying on the employees to remain vigilant in reviewing logs, ensuring consistency in following procedures and being as productive as possible to respect the requested deadlines. With AI-based solutions, CAPA is automatically initiated as soon as an error is registered, therefore removing the need for manual labor and inconsistencies due to the human factor. The automated process issues a notice that CAPA was activated, appropriate corrective actions are automatically applied to the identified deviation, and previous preventive actions are checked for similar deviations to strengthen the effectiveness of the CAPA process. Therefore, any issues with reliability, defect tracking software or promptness of response have been removed. Benefits of Artificial Intelligence and Machine Learning in Quality Management To briefly define these tools, artificial intelligence uses human-like processes for planning, analyzing and problem solving. Its subsets are machine learning and deep learning. Machine learning performs endless calculations of the collected data to suggest possible solutions to the imposed problem, using systems modeled to resemble a human brain. Deep learning uses algorithms to process vast amounts of data through many layers in order to transform it into usable chunks of information. All of these processes can be done quickly, even on an extremely large amount of data. As a result, these technologies produce meaningful insights that can solve problems, predict likely scenarios, or serve to improve the manufacturing processes. And they do it promptly, practically and without prohibiting costs. Furthermore, there is no need for previous categorization or complicated data integration. On the contrary – AI performs better when data is unstructured, even when it is collected from different sources and in various formats. This greatly simplifies the procedure of gathering data from different parts of the manufacturing process, from various devices and systems, even from separate departments, without having to create uniform reports or formatted data sheets. Raw data is being indexed, stored and then quickly analyzed whenever the need arises, thus significantly improving the data analytics in QMS. How can Machine Learning be used in Quality Management Processes? As an example, procedures for handling customer complaints are defined as part of the Good Manufacturing Practice for the pharmaceutical industry. Since these usually relate to substandard medicines or medical devices, they do need to be addresses immediately and through an effective course of action. Implementation of machine learning through AI allows to create a unified, automatic process of registering and acting upon these events. Rather than relying on several departments operating independently on limited data, an automated solution provides a prompt reaction with real-time tracking of a complaint. The issue is resolved through effective corrections and if necessary, the complaint

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February 6, 2024

Top 9 Challenges and Solutions for eDMS Software in Pharma Industry

The pharmaceutical industry operates in a highly regulated and complex environment, facing numerous challenges that can impact productivity, compliance, and overall efficiency. Managing documents from several sources becomes challenging and time-consuming. However, eDMS Software is a power-packed electronic document management system exclusively designed for Pharmaceutical and Biotech companies, developed, and implemented exclusively to meet the cGMP needs of the Pharma domain with 21 CFR Part 11 compliance, EU Annex 11 compliance can easily eliminate all the challenges faced by different companies. Below are the few regulatory bodies that offer guidelines for generating, handling, and maintaining the journey of a drug development process. However, the electronic document management system (eDMS) has become a game changer in today’s era. It is vital for the smooth functioning of the pharma operation in today’s complex and collaborative work environment. Simultaneously, eDMS addresses the challenges faced by the pharma industries in the recent scenario. In this article, we deep-dive into some of the most common issues faced by the pharma industries. eDMS paves path for transformative change In recent years, the pharmaceutical industry has witnessed a significant transformation driven by advancements in technology. This digital solution has been instrumental in streamlining processes, improving efficiency, and ensuring compliance across the pharmaceutical sector. No doubt it has become a game-changer by enhancing document control, improving regulatory compliance, enabling efficient information retrieval, ensuring data security, and streamlining audits. As a result, eDMS empowers pharma companies to operate more effectively in a highly regulated environment and like SOPs, Protocols, Specifications Annexures and more. As the industry continues to evolve, eDMS will continue to play a crucial role in supporting innovation, collaboration, and overall success in the pharmaceutical sector. Moreover, the eDMS can be integrated with pharma electronic quality management software and digital learning management systems due to its robust document control capabilities, designed to manage documents more effectively and efficiently while ensuring compliance with all the applicable regulatory requirements. Also, the Software can incorporate various document formats. Types of documents that can be uploaded in the DMS Software Key Pharmaceutical Industry Challenges & Solutions of eDMS Software eDMS has come a long way and overtaken paper-based traditional systems as part of the shift towards greater transparency, making data increasingly searchable, accurate, easy data sort, store, retrieve, archive, and difficult to forge. Let us now have look at how eDMS solves the issues faced by the pharma industries: 1. Document Accessibility from Tab, Mobile, or Web Browser: eDMS platforms are designed to provide seamless access to documents from various devices, including tablets, mobile phones, and web browsers. With responsive web interfaces or dedicated mobile applications, authorized users can conveniently retrieve, review, and collaborate on documents regardless of their location or the device they are using. This feature enhances workforce mobility, facilitates remote work, and promotes efficient decision-making. 2. Mandatory Review based on Knowledge Gained on LMS Content: Integrating eDMS with Learning Management Systems (LMS) enables a streamlined process for mandatory document reviews. When employees complete training or gain specific knowledge through the LMS, the eDMS Software can automatically trigger document review assignments based on predefined criteria. This integration ensures that personnel with relevant expertise or newly acquired knowledge review and validate documents promptly, improving compliance and reducing delays. 3. Print Controls, Additional Copy Prints, Reprints: eDMS Software offer robust print controls to manage document printing within the organization. Administrators can set permissions and restrictions on printing, limiting the number of copies, and controlling who can print documents. This feature helps prevent unauthorized distribution of sensitive information, reduces unnecessary printing costs, and ensures that only approved printed copies are generated, eliminating the risk of outdated or uncontrolled prints. 4. Issuance of Documents (Controlled Copies, Drafts, Uncontrolled Copies, and Training Copies): eDMS facilitates the issuance of different document versions and types as per the defined requirements. Controlled copies, which are official and approved versions, are securely stored within the eDMS repository. Drafts allow for collaborative editing and review before final approval. Uncontrolled copies are made available for reference purposes, typically with restricted editing rights. Additionally, eDMS can manage the issuance of training copies, ensuring that the latest version of documents is available for training purposes, maintaining consistency and accuracy. 5. Reconciliation of Issuance: Reconciliation of document issuance is a critical process to ensure that the right versions of documents are distributed and accounted for. Hence, it simplifies this task by maintaining a centralized record of issued documents. It tracks the issuance status, identifies discrepancies, and provides real-time visibility into the location and status of each document. This reconciliation feature helps eliminate errors, minimize the risk of non-compliance, and ensures accurate documentation throughout the organization. 6. Version Management to Avoid Deviations on Timely Management of Versions: eDMS platforms excel at version management, ensuring that the correct document versions are used throughout the organization. By maintaining a clear version history, eDMS enables easy identification of the latest approved version and highlights any deviations or outdated versions. Notifications and alerts can be set up to inform users when a new version is available, minimizing the chances of using incorrect or obsolete documents. This feature promotes compliance, reduces errors, and fosters adherence to standardized procedures. 7. Watermarks: eDMS Software provide the option to add watermarks to documents, enhancing document security and control. This feature helps prevent unauthorized distribution, discourages unauthorized modifications, and maintains document integrity. 8. Change Control Integration and LMS System Integration: eDMS platforms often integrate seamlessly with change control systems and LMS systems. Change control integration ensures that any changes made to a document, such as revisions or updates, follow a defined change control process, allowing for proper review, approval, and documentation of changes. Integration with LMS systems ensures that employees have access to the latest versions of documents aligned with their training records, promoting consistency and compliance. 9. Anytime Reference of SOPs in Shopfloor: eDMS enables real-time access to Standard Operating Procedures (SOPs) from the shop floor or any other work area. By accessing the eDMS system through devices such as tablets or mobile devices, employees can instantly refer to relevant SOPs, work instructions, or guidelines while performing

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February 6, 2024

AmpleLogic: Offering GMP Quality Management System to Achieve Optimum ROI

The aging population, chronic and lifestyle diseases, emerging-market expansion, and treatment and technology advances are expected to spur life sciences sector growth in 2015. Furthermore, efforts by governments, health care providers, and health plans to reduce costs, improve outcomes, and demonstrate value is dramatically altering the health care demand and delivery landscape. The Pharma and the Life Science companies are now depending on IT solutions to effectively evaluate tomorrow’s challenge, which is to develop new medicines that can prevent or cure currently incurable diseases. However, depending heavily on IT vendors will not do much good in the long run as increased spending on applications for data analysis and related technologies for efficiency and better automation will result in imposing a weighty yoke on the finance division of the company, while the in- house R&D and IT team lies dormant. Organizations should invest in good architecture, scalable rapid app development platforms and build internal IT Teams to automate the Business Processes. Headquartered in Hyderabad and having offices at the USA & Singapore AmpleLogic stresses the importance of, Pharma and Life Science companies investing in managing their internal IT departments effectively with meager help from outside vendors. AmpleLogic offers ready to use apps in the Pharma Business Process area without coercing their clients in any way to adopt their solutions. AmpleLogic offers GMP Solution in the areas of Quality Assurance, Quality Control, Packing, Production and Engineering, Sales and Marketing solutions in the Pharma domain. After a considerable amount of Research, Dedication, and Investments, AmpleLogic has developed Enterprise Automation, an automated GMP (Good Manufacturing Practice) Quality Management (QMS) System. “The Enterprise automation is specifically developed for Life Science Companies to manage the Quality standards within their organizations. The web-based rapid Application Development platform delivers complete business process automation within a short interval of time thus contributing to ROI,” says, Venkanna Chowdary Manne, MD AmpleLogic. Recently, AmpleLogic helped one of India’s largest Pharma Company, who wanted to have an online and offline data storage for sales and marketing team, by developing a unique excel component that ensures efficient user experience. Realizing their client’s varied demands, despite sharing the same industry, AmpleLogic provides an array of customer-specific solutions. The company helps its clients with BIMS (Batch Record Issuance Management), along with this; the company also succeeds in helping them with a smooth transition to eBMR. AmpleLogic proffers adaptable graphical interface builders so that their solutions ensure complete competency into the client’s SOP’s while being cost effective. Furthermore, AmpleLogic assures safety and security when sharing the login credentials by implementing a bio metric authentication. Additionally, the company helps its clients in automating their QMS area. Established in 2010, AmpleLogic has been working with companies like Dr. Reddys, Hetero, Natco, Granules, Bharat Bio-Tech to name a few. Observing the rate at which AmpleLogic is treading the Pharma and Life Science domain, it is only prudent to say that the company will be successful in helping CIOs of the companies in this sector to fully harness IT to their advantage. In India Best Technology Magazine Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom (UK)United States (US)United States (US) Minor Outlying IslandsUnited States (US) Virgin IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabweWhere you heard about us?– Select –Google SearchLinkedInReferralWord of MouthLinkedIn AdsMediumRequirementGet in touch

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February 6, 2024

Remarkable height of digitalization in Pharma Businesses with DMS

Go Paperless with Document Management System Gone are the days when we used to keep all our essential information and crucial data in tones of logbooks. Here comes the new era with new innovative options to get those things done without any hassle, Electronic Document Management Software. When you have a lot of data to input, limiting to manual documentation becomes exhausting, expensive, and time-consuming. Whereas with this digital add-on the entire documentation task in contemporary pharma and life sciences industries are being managed easily with organized creations of automated documents. Helping several businesses to organize their paper works digitally, with EDMS companies are now transforming themselves from paper-based to completely paperless, which is more resolved and easier to access. Coming up with a lot of helpful features, EDMS is the one that all businesses need to incorporate in their whole-sole documentation category inviting further business growth. Successful business accomplishment with eDMS With FDA’s 21 CFR part 11 regulation, it has been clarified that all the electronic records including signature and other documents will be treated as the final ones replacing the paper-based records. This has ultimately given us a sign that contemporary life sciences, pharma and biotechnology industries should take a step ahead accepting this effective-cum-painless digital trend. With Electronic Document Management, automatic feeding of data to tracking it down with needed information and further documentation has really become an uncomplicated process. Let’s celebrate this user-friendly innovation with certain benefits it has given to pharma businesses battling with some crucial challenges. Starting from document creation, review, approval, edit, rework, everything used to be handled with manual interferences, whereas eDMS has brought all these tasks into a proper streamline where every stage is managed automatically with no or rare human intervention. When this manual documentation takes a lot of quality time as an investment, the whole streamline breaks if one employee is not staying updated with the whole process. Hence, it is altogether a break of workflow as well as time-intensive work. On the other hand, eDMS will maintain the entire workflow consuming minimal time, and the rest quality time can be used in other areas of growth. In a pharma business or life sciences company, there occurs frequent changes in the regulatory and certain compliances. Keeping a tab on all those recent updates becomes a tough job with manual documentation. Whereas, with eDMS you stay updated about all those changes and have a keen observation of the whole track activities. Ever thought where to keep those shedloads of documents? What will you do when you have an urgent meeting to look after and the file you are searching for is missing? And here comes another advantage of EDMS Software. Manage a common hub for all your important data collectively under one cloud and access easily whenever required. Manual feeding means a huge chance of missing some important data or incorrect data input or mismatch of data inserted. We certainly cannot avoid these terrific situations in manual management, but these can be resolved with automatic eDMS, where you get instant reminders, notifications, or escalation pop ups immediately the software finds any error in data or needs revision of data. Documentation is not only restricted to maintaining the paperwork’s, but along with the data it is also required to keep an eye on parallel departments like production, operation, quality assistance, etc. This can be done smoothly with the help of Document Management Software whereas it’s a tougher manual task. In an organization where a lot of employees do work, keeping their data is really hard work and sometimes we miss data which could create trouble afterwards. Well, with DMS each detail of all the employees is being secured under the shed of a specific cloud and it is easily accessible through secured and personalized credentials. When we keep or preserve data using DMS instead of manual documentations there is no chance that a natural calamity or fire attack in the storage area will destroy the data. This is high time when every business is transforming themselves from human-operated to automated, Document Management System of AmpleLogic is encouraging budding as well as established pharma and life sciences companies to enlarge their scope of digitalization with a smart modern touch. Its motto is to channelize end-to-end digitalization in several pharma industries with the impact of trending Pharma 4.0 and full-fledged automation.  Schedule a call with the AmpleLogic team to enroll for a free demonstration of Electronic Document Management System Software. Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom (UK)United States (US)United States (US) Minor Outlying IslandsUnited States (US) Virgin IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabweWhere you heard about us?– Select –Google SearchLinkedInReferralWord of MouthLinkedIn AdsMediumRequirementGet in touch

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April 10, 2023

A Comprehensive Insight on Various Audit Types in Quality Management

Quality audits specifically examine how well product designs and processes meet specified standards and regulatory compliances. They are performed periodically by internal people within the organization or externally by a quality auditor or an audit team. Quality Audit is an essential part of product processing, testing, and the product distribution system, especially in regulated industries where manufactured goods come in direct contact with the users. Industries such as Lifesciences, Medical Devices, Food and beverages, Beauty and Cosmetics, Gene Therapy, etc, fall under this category. Other industries have their own set of quality audits, but these sectors need specialized attention. Quality audits in these fields are, hence, known to be rigorous. Quality Audits Definition Quality audits are independent, systematic evaluations of processes, systems, and products within an organization. It helps in determining business compliance with standardised procedures, current regulations and best practices. During quality audits, if any gap is identified, the situation is assessed to understand the impact on the product. Also, investigation is carried out to find the root cause of the gap. Accordingly, appropriate corrective and preventive action is implemented to eradicate similar issues in the future. Why is Quality Audit Essential? Quality audits help companies access their performance and record outcomes in documents. This is the best way businesses can optimize their growth and generate more revenue. Companies can benefit in the following ways from Quality audits: Robust Monitoring Mechanism Improvement of Product Quality Ensures Error-free Processes Promotes thorough Authentication Assists in Regulatory Compliance Effective Quality Tactics Enhances Productivity Ensures Product Uniformity Reduces Errors Reduces Wastage of Resources and Manpower Perfect Documentation Cost-Effective   Types Of Audits In Quality Management Internal Quality System Audit: Evaluation of systems and processes within an organization is called Internal Quality System Audit. It ensures effectiveness, compliance, and improvement of internal quality management processes. Carried out by internal professionals and quality assurance teams, internal quality system audit helps companies identify areas for improvement, thus fostering operational excellence. Supplier Audit: Businesses need to evaluate external suppliers based on criteria such as time, product quality, cost-effectiveness, and certification to ensure they meet the quality standards of the organization. Real-time transparency obtained from supplier audits helps businesses and suppliers jointly monitor purchase order activities and address issues of errors and non-conformities. Production Team Audit: Audits on the activities performed by the production team is called Production Team Audit. Businesses audit their actions for operator acceptance or certified operator programs. This is done to requalify their skills. Auditors review training records, change in processes and past activities to ensure that everything meets quality standards. Safety Audit: This is one of the essential audits operational in organizations. Safety audits help companies keep their employees safe by reviewing equipment and evaluating the safety steps at place. Companies need to have structured policies to prevent accidents or injuries. This enables safer environment for all employees. Facilities Audit: The audit keeps a check on the quality of an organization’s assets such as buildings and equipments. Auditors need to monitor ACs, HVAC (heating, ventilation, and air conditioning), water tankers, manufacturing equipment, technology, etc. Such audit ensures safety and improves quality outcomes. Environmental Audit: Environmental audits ensure that workplaces are free from pollution and toxins. It helps identify potential risks and build plans to meet safety standards like cGMP, OSHA, etc. The audit team additionally keeps check on employees for following the standards and usage of proper disposal techniques. Risk Assessment Audit: The risk assessment audit especially helps in identifying workplace risks. Each risk is put under certain categories and aligned measures are specified to prevent quality issues, accidents, machine failures, natural disasters, etc. Design Control Audit: It ensures businesses follow proper, compliant, and systematic methods to produce safe and high-quality products. The audit team designs plans, provides inputs and outputs to observe that specific criteria are met, and potential risks are analyzed before occurrence. Regulatory Audit: This audit ensures that organizations follow specific guidelines laid down by regulatory agencies. Auditors not only review quality practices but also gather important data to check grey areas where rules are not being followed. Method Validation Audit: Regulatory bodies such as FDA put forward method validation audit to check if testing methods in manufacturing are standardized, consistent and well documented. It emphasizes the reliability and accuracy of products made by humans. Why Quality Management Software? Managing audits manually can be tedious and prone to errors. QMS software in such a scenario, can really be the best solution! Quality Management Software takes care of quality audits and keeps track of all business operations. The solution comes with seamless data integration and guaranteed authentication that ensures transparency and accuracy. Businesses have been leveraging on Quality Management Softwares (QMS) to guarantee process and product quality and, compliance with regulations. AmpleLogic’s eQMS software is specially crafted for highly regulated sectors such as Lifesciences, Medical Devices, Food & Beverages, Beauty and Cosmetics, Gene Therapy and so on. AmpleLogic’s eQMS software renders 11 specific modules: CAPA, Change Control, Market Complaints, Deviations, Audits, Vendor Qualification, Out of Specification, Out of Trend, Lab Incident Reporting. All these modules are seamlessly integrated with one another. AmpleLogic eQMS System AmpleLogic also has other COTS products like Document Management System (DMS), Learning Management System (LMS), Regulatory Information Management System (RIMS), Electronic Batch Management System (eBMR), Environmental Monitoring Software (EMS), etc that are integrated with eQMS to offer best quality management! How is AmpleLogic’s eQMS the Best Solution? Round-the-Clock Accessibility Peaked for Perfection Quick Alerts and Prompts Guarantees Reviewed and Verified Processes Keeps Track Records Built-in Emailing Feature Appealing Visual Representation No Geographical Hindrances Enhanced Transparency Compliant to International Regulations such as US FDA 21 CFR Part 11, EU Annexure 11, GAMP 5 standard, GMP, Alcoa+ Principles, etc To gain a more in-depth understanding of our eQMS product, request a demonstration at: Click here to Request Demo Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern

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April 10, 2023

Revolutionizing Regulated Industries: Unleashing the Power of aPaaS with COTS and Low-Code Platforms

In the ever-evolving landscape of regulated industries such as life sciences, pharmaceutical manufacturing, gene therapy and medical devices; the demand for cutting-edge technology solutions is paramount. As these sectors strive for innovation while adhering to stringent regulations as per electronic records guidelines defined in US FDA 21 CFR Part 11, EU Annexure 11 and GAMP 5 category standards; it becomes imperative to explore platforms that can seamlessly blend customization features with efficiency and provide integration among business processes. The regulated companies have finely leveraged cloud technology to streamline business activities that address current cyber security challenges and provide customized solutions. These service offerings consist mainly of Software-as-a-Service (SaaS) and Platform-as-a-Service (PaaS). But more often than not, these companies require customized solutions for their unique needs instead of just standard solutions. Now, before delving into the same let’s first understand what are cloud solutions and their types. Cloud solutions refer to computing services and resources delivered over the internet, commonly known as the cloud. These services include a variety of applications, storage, processing power, and more, enabling users to access and use these resources remotely rather than on their local devices or servers. A private cloud is hosted, used and maintained by a single organization. This means it is a dedicated cloud that is solely used by an individual company who has overall control over the infrastructure and its services. Ensures complete autonomy. They can customize the environment according to their own needs. Companies meet their compliance requirements better. Higher security and reduced chances of cyber attacks since data is not shared, chances of security breaches are reduced significantly. Public cloud is a third-party managed platform that is used by multiple companies to do their regular tasks. This setting relieves companies from owning or maintaining their own infrastructure. Public cloud resources usually include virtual machines, applications and storage. Cost effective as companies don’t have to maintain their own infrastructure. Offers higher agility and scalability, can increase or decrease resources as required without impact of increasing or decreasing workload and fluctuation in business requirements. Promotes efficiency. Pay for what you use. Types of Cloud Models Broadly there are three types of cloud models: In the IaaS (Infrastructure as a Service) model, vendors offer the entire cloud infrastructure including hardware, computing resources and data centres. This way the end user can access the hardware over the internet while paying for the service. Usually, companies sign up for virtual machines or they go for a dedicated hardware for their personal usage. In the PaaS (Platform as a Service) model, vendors provide users with a development and deployment environment where clients build their own applications and software. PaaS is a great solution for businesses who want personalized softwares. A low to no code environment additionally helps companies build applications with no prior knowledge of programming languages. Among the three Cloud models, SaaS (Software as a Service) is by far the most popular! In this model, companies offer their own software or applications to clients. It is the vendor who then takes care of the maintenance of these software. They are also responsible for the updates. Users get generic applications with SaaS. Irrespective of SaaS’ high demand, regulated industries seek personalized solutions. As new technologies seep in every day, a sub-model of PaaS – aPaaS – outshines as a better alternative for automating highly regulated industries. Let’s look at this article to explore the benefits of adopting an Application-Platform-as-a-Service (aPaaS) solution over traditional Software-as-a-Service (SaaS) model, highlighting the advantages and proposing a novel approach – aPaaS with Commercial Off-The-Shelf (COTS) products – for enhanced adaptability, time efficiency, cost management and building of business-centric solutions without developing them from scratch. Challenges with SaaS in Regulated Industries 1. Customization Roadblocks: Traditional SaaS solutions often come with predefined features and limited flexibility, creating roadblocks for organizations in regulated industries such as in the lifesciences, pharmaceuticals, and medical devices that have unique workflows and compliance requirements such as US FDA 21 CFR Part 11, EU Annexure 1, GAMP 4 & 5 category standards. Although in private cloud, customization is possible but comes with very high cost and maintenance. 2. Limited Control Over Updates: In regulated environments, controlling the timing and impact of software updates is crucial. SaaS solutions may force updates that can disrupt workflows. To ensure processes run smoothly and as expected companies need to validate the updates which is pretty time consuming and shoots up costs. SaaS Advantages and Disadvantages 3. Integration Issues: No service provider typically offers a comprehensive suite of SaaS products that fully meet a business’s diverse needs. This leads organizations to depend on multiple SaaS providers, resulting in the management of multiple accounts and an associated high cost of integration. 4. Added Costs: Services from multiple vendors for different products also involve additional costs. Additionally, standard Service Level Agreements (SLAs) offered by SaaS providers may not be sufficient for regulated environments, requiring negotiations for enhanced uptime, security, and data recovery guarantees, which would be an added cost to the organisations. This is a key issue as every company runs on a specific budget. The Essence of aPaaS in Regulated Industries 1. aPaaS as a Subset of PaaSRecognizing aPaaS as a subset of Platform as a Service (PaaS) sheds light on its specialized role in providing tailored solutions for application development. aPaaS providers leverage Low Code No Code (LCNC) methodologies, making application development more accessible and efficient. 2. LCNC MethodologyThe LCNC methodology empowers businesses to rapidly develop applications, reducing time-to-market. By offering Low Code platforms on their cloud infrastructure, service providers facilitate the creation of customized applications without the need for extensive coding expertise. 3. Customization BenefitsOne of the key advantages of developing products on such Low Code platforms is the flexibility they offer to accommodate customer-specific requirements. This adaptability is particularly beneficial when organizations seek tailored solutions to meet their unique business needs, enabling a more agile response to changing market dynamics. Users get this advantage when they opt for an aPaaS platform. 4. Deployment Methods There are two ways of deploying an aPaaS platform: On Cloud: Usually, aPaaS

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8 common GCP violations in clinical trials
April 10, 2023

8 Common GCP Violations in Clinical Trials

Clinical trials are crucial for advancing medical research, but ensuring their integrity and adherence to ethical guidelines is paramount. Good Clinical Practice (GCP) guidelines serve as the backbone, dictating the ethical conduct and quality assurance in these trials. However, violations of these guidelines can occur, leading to various repercussions for both participants and trial outcomes. What are GCP Violations? GCP Violations refer to instances where clinical trials deviate from the prescribed guidelines and regulations set forth by international bodies such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and regulatory agencies like the FDA or EMA. These violations encompass a range of discrepancies that compromise the integrity, validity, and ethical standards of clinical research. 8 Common GCP Violations Here are 8 most common instances of GCP violations observed in clinical trials. 1. Failure in Informed Consent Procedures: Inadequate or improper informed consent processes are a prevalent violation. Participants must fully comprehend the nature of the trial, potential risks, and benefits before enrollment. Failure to provide comprehensive information or ethically obtain informed consent can result in serious breaches. 2. Inadequate Record Keeping: Accurate and comprehensive record-keeping is pivotal in clinical trials. Violations in this aspect, such as missing or falsified documentation, can severely impact the credibility and reliability of trial data. 3. Protocol Deviations: Deviating from the approved research protocol is another common violation. Straying from outlined procedures compromises data accuracy and can undermine the study’s integrity. 4. Lack of Investigator Oversight: Insufficient oversight by investigators can lead to various violations. Lack of supervision might result in poor participant monitoring, incorrect drug administration, or failure to promptly report adverse events. 5. Data Falsification or Fabrication:  Perhaps one of the most serious violations, fabricating or falsifying trial data undermines scientific credibility and poses significant risks to participant safety. 6. Poor Drug Accountability:  Inadequate monitoring and documentation of investigational drugs, including storage, dispensing, and tracking, can lead to serious compliance issues. 7. Inappropriate Subject Selection: Choosing unsuitable participants for a trial can compromise the study’s validity and the safety of individuals involved. 8. Insufficient Monitoring: Lack of rigorous monitoring throughout the trial duration can lead to unnoticed violations and compromise data integrity. Impact of GCP Violations GCP violations have multifaceted impacts, affecting participant safety, trial outcomes, and overall scientific validity. The repercussions extend to regulatory scrutiny, legal actions, and reputational damage for involved parties. Ways to Prevent GCP Violations Preventing GCP violations requires a proactive approach involving robust training, stringent quality assurance measures, meticulous monitoring, and clear protocols. Case Studies Examining real-life examples of GCP violations and their consequences sheds light on the seriousness of non-compliance and its implications. Regulatory Response and Penalties Regulatory bodies enforce strict actions and penalties for GCP violations to uphold ethical standards and ensure compliance. Importance of Ethical Conduct in Clinical Trials Upholding ethical conduct is pivotal in preserving participant safety, maintaining trial integrity, and advancing credible medical research. Conclusion Ensuring adherence to GCP guidelines is imperative in conducting ethical and reliable clinical trials. Straying from these principles not only risks participant safety but also undermines the validity and credibility of scientific advancements. Upholding Good Clinical Practices remains central to the responsible and impactful progression of medical research. Only by abiding by these practices can we really foster safety and have assured success. Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom (UK)United States (US)United States (US) Minor Outlying IslandsUnited States (US) Virgin IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabweWhere you heard about us?– Select –Google SearchLinkedInReferralWord of MouthLinkedIn AdsMediumRequirementGet in touch

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April 10, 2023

Streamlining Pharmaceutical Manufacturing with DMS Software

Maintaining strict quality standards, efficient processes, and compliance with regulatory requirements is paramount in the highly regulated and complex pharmaceutical industry. Document control plays a pivotal role in ensuring that manufacturing processes are well-documented, consistent, and adhere to regulations such as Good Manufacturing Practices (GMP) and the Food and Drug Administration (FDA) guidelines. To achieve these goals, pharmaceutical companies increasingly use document control software solutions. Document Control Challenges in Pharma Manufacturing Pharmaceutical manufacturing involves a multitude of processes, from research and development to production, testing, and distribution. With numerous stages and departments involved, managing documents manually can become overwhelming and error-prone. Some of the challenges faced include: Version Control: In a dynamic manufacturing environment, documents such as Standard Operating Procedures (SOPs), batch records, and work instructions are frequently updated. Keeping track of the latest version and ensuring all relevant stakeholders can access it can be challenging. Compliance and Audits: Regulatory bodies demand pharmaceutical companies to maintain accurate and up-to-date documentation to ensure product quality and patient safety. Preparing for audits and inspections can be time-consuming and stressful without proper document management. Collaboration: Collaboration among various departments and teams is essential in the pharmaceutical industry. Ensuring that the right people can access the right documents while maintaining control over editing and changes. Traceability: Tracking changes made to documents is vital for accountability and meeting regulatory requirements. Manually tracking modifications can lead to errors and inefficiencies. Security: Protecting sensitive information and maintaining data integrity are paramount. Unauthorized access to critical documents can have serious consequences. Benefits of Document Control Software: Document control software designed for pharmaceutical manufacturing addresses these challenges and offers numerous advantages: Version Control: Automated document control software ensures that only the latest version of a document is accessible. It eliminates confusion caused by outdated documents and prevents the use of incorrect procedures. Centralized Repository: All documents are stored in a centralized digital repository, accessible to authorized personnel from different locations. This streamlines information sharing and collaboration. Workflow Automation: Document control software can automate approval workflows, ensuring that relevant stakeholders review and approve changes before implementation. Audit Trail: An electronic audit trail captures all changes made to documents, including who made the change and when. This feature simplifies audits and ensures accountability. Access Control: Role-based access control ensures only authorized personnel can access, view, edit, or approve documents. As a result, it enhances security and prevents unauthorized modifications. Search and Retrieval: Advanced search capabilities allow users to quickly locate specific documents, reducing time spent searching through physical files or shared drives. Electronic Signatures: Digital signatures provide a secure way to approve documents, and regulatory agencies legally recognize them. Integration: Many document control solutions can integrate with other quality management systems and tools, creating a seamless ecosystem for managing processes and documentation. Choosing the Right Document Management Software: When selecting document control software for pharmaceutical manufacturing, consider factors such as: Regulatory Compliance: Ensure that the software meets industry-specific regulations and guidelines. Customizability: The software should adapt to your company’s unique processes and workflows. User-Friendly Interface: The software should be intuitive and easy for all users to navigate. Scalability: Choose a solution that can grow with your company’s needs and evolving regulatory requirements. Security: Robust security features, encryption, and user access controls are essential. Support and Training: Look for a provider that offers adequate support and training to ensure successful implementation. Conclusion In conclusion, document control software plays a vital role in streamlining pharmaceutical manufacturing processes, ensuring compliance, and maintaining product quality. By adopting the right software solution, pharmaceutical companies can improve efficiency, reduce errors, and enhance collaboration while meeting the industry’s stringent requirements. Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom (UK)United States (US)United States (US) Minor Outlying IslandsUnited States (US) Virgin IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabweWhere you heard about us?– Select –Google SearchLinkedInReferralWord of MouthLinkedIn AdsMediumRequirementGet in touch

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April 10, 2023

Achieving data integrity is made easy with eDMS in the pharmaceutical industry

Data integrity reaffirms the pharmaceutical industry’s commitment to manufacturing safe, effective drugs that satisfy quality standards. Simultaneously, data integrity is a vital tool for regulatory authorities to employ in protecting public health. Recent FDA Form-483 observations and warning letters reveal that data integrity is the major issue the pharmaceutical industry is currently dealing with. Failure to comply with data integrity requirements may result in many un-validated results, which may cause post-marketing issues and frequent product recalls. Therefore a comprehensive approach is necessary to address the underlying causes of data integrity problems, which lead to poor quality culture, organizational or individual behavior, leadership, processes, or technology. Therefore, appropriate software is vital for enforcing practices necessary for compliance and easing the burden for both parties. This software’s functionality supports audit trail maintenance and review and streamlines systems to enhance productivity. Industry trends shaping audit demands In recent years, the focus on data integrity has intensified, followed by warning letters, notices of concern and statements of non-compliance. Authorities seek to reduce incidents of poor data integrity by promoting transparency and revamping regulatory guidelines related to pharmaceutical manufacturing. Electronic data systems have overtaken paper as part of the shift towards greater transparency, making data increasingly searchable, accurate, and difficult to forge. The enforcement of ever-evolving audit trail regulations is driven by one underlying factor, which is the demand for high-quality products. To this end, the US Food and Drug Administration (FDA) is considering novel strategies for incentivizing mature quality management systems. Moreover, FDA has suggested introducing a rating system for pharmaceutical companies. Here, they can reveal a rating indicative of their commitment to establishing quality management systems that help anticipate problems before they arise. As a result, this move would provide companies with robust quality management maturity and competitive advantage, potentially allowing them to grow their market share. Data integrity is essential for reshaping the pharmaceutical industry and triggering significant innovation to ensure the information’s reliability and trustworthiness. In the future, the significance of implementing measures and practices that frame the integrity of the collected data through the whole life cycle of a product will increase. Now, companies that have started implementing the DI practices and a DI program will likely gain considerable advantages over their competitors. Certainly, here are some points highlighting how achieving data integrity is facilitated by using an electronic Document Management System (eDMS) in the pharmaceutical industry: Centralized Storage: eDMS provides a centralized repository for all documents and data, ensuring easy access, retrieval, and management of critical information. Version Control: The system records document versions, revisions, and updates, minimizing the risk of using outdated or incorrect information. Audit Trail: eDMS creates an electronic audit trail that captures user actions, edits, and document history, offering transparency and accountability. Role-based Access: Access controls and permissions are enforced, limiting document access to authorized personnel enhancing security and confidentiality. Electronic Signatures: Digital signatures add an extra layer of authenticity to documents, making them legally binding and tamper-proof. Workflow Automation: Automated approval workflows streamline document review and approval processes, reducing human errors and accelerating document lifecycle. Data Integrity Checks: eDMS can include built-in data integrity checks to ensure accurate data entry and prevent inconsistencies. Validation and Compliance: eDMS platforms can be validated to comply with industry regulations like 21 CFR Part 11, EU Annex 11, and GxP guidelines. Reduced Paper Usage: By transitioning from paper-based to electronic processes, errors due to manual data entry are minimized. Real-time Collaboration: Teams can collaborate on documents simultaneously, promoting real-time feedback and updates while maintaining data integrity. Search and Retrieval: Advanced search capabilities in eDMS enable quick retrieval of documents, reducing time spent on data searches. Backup and Disaster Recovery: eDMS systems often include data backup and recovery mechanisms, safeguarding documents against loss or corruption. Regular Audits: The system supports regular audits and inspections, ensuring data integrity and regulatory standards compliance. Data Validation: eDMS can include validation checks to ensure data accuracy, completeness, and adherence to predefined formats. Training Records: eDMS can manage training records, ensuring that personnel accessing documents are adequately trained and qualified. Consistency Across Sites: Multisite organizations benefit from standardized processes and data integrity practices across various locations. Compliance and workflows are made easy with Amplelogic’s Document Management System (DMS) The pharmaceutical industry is under immense pressure to show greater transparency and data integrity to provide a reliable supply of high-quality pharmaceutical products. Accurate and evolving audit trail regulations reflect the necessity to safeguard public health and represent a primary challenge for manufacturers. To remain compliant, manufacturers demand software systems qualified to handle all datasets without compromising productivity. Therefore, implementing an Amplelogic DMS helps you to achieve compliance, simplify audit trail reviews and enhance workflows. Here are a few features of Amplelogic’s DMS to simplify compliance and audit trail reviews: A user can develop templates for any document kinds, and the workflow can be set according to the SOP. It keeps track of the most recent version of every document created and makes it easy to access that version. Integrates with other systems, such as Quality Management Systems (QMS), Learning Management Systems (LMS), and so on, to simplify document preparation and handling. The dashboard displays all the pending tasks of the end user. An archiving mechanism helps the data to be archived at a predetermined time frequency based on the company’s SOP. To learn more about our software, click on this link to explore. Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom

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April 10, 2023

Top 7 Queries Addressed: Data Integrity and CGMP Compliance

This article provides a clear insight into the significance of data integrity within the framework of current good manufacturing practice (CGMP) for pharmaceuticals, as mandated by 21 CFR parts 210, 211, and 212. These parts encompass the regulations for Current Good Manufacturing Practices in Manufacturing, Processing, Packing, or Holding of Drugs in general (part 210), Current Good Manufacturing Practices for Finished Pharmaceuticals (part 211), and Current Good Manufacturing Practices for Positron Emission Tomography Drugs (part 212). This guidance outlines the Agency’s perspective on the creation and management of data in accordance with CGMP requirements. Therefore, the core principle this guidance upholds is the insistence on reliability and accuracy in data. The FDA emphasizes the need for data to be dependable and precise. To address data integrity concerns, the CGMP regulations and associated guidance advocate for adaptable and risk-based approaches. These approaches are intended to prevent and detect issues related to data integrity. In doing so, pharmaceutical firms are encouraged to implement strategies that effectively manage data integrity risks, leveraging their comprehension of processes, technological insights, and business models. It’s important to note that the guidance documents issued by the FDA express the Agency’s current perspectives and beliefs. These documents do not establish legally binding obligations. Rather, they offer recommendations based on the FDA’s present understanding. However, using terms like “should” in these guidances indicates suggestions and recommendations, but they are not obligatory unless specific regulatory or statutory mandates are explicitly cited. Let’s take a deep dive into the top 7 questions below 1. When is it permissible to exclude CGMP data from decision-making?   Every data formed within the context of a CGMP record needs to be evaluated by the quality unit for release criteria and preservation per CGMP objectives. Electronic data generated to satisfy CGMP obligations should encompass pertinent metadata. To omit data from the decision-making process for release criteria, a valid and well-documented for its exclusion should exist. The prerequisites for retaining and reviewing records remain consistent irrespective of the data format; paper-based and electronic data record-keeping systems are subject to identical stipulations. 2. Why is the FDA concerned with using shared login accounts for computer systems?  It is essential to enforce suitable measures to guarantee that alterations to computerized Master Production and Control Records (MPCRs) or other records and the inputting of laboratory data into computerized records are conducted solely by authorized personnel. Concurrently, implementing documentation controls is imperative to ascertain that actions can be unequivocally attributed to specific individuals. In instances where login credentials are shared, the distinct identification of an individual through the login is rendered unfeasible, resulting in non-conformance with the CGMP requisites delineated in parts 211 and 212. FDA mandates that the design of system controls, including documentation controls, adhere to CGMP principles to ensure the preservation of product quality. 3. How often should audit trails be reviewed?  FDA advises conducting reviews of audit trails that document alterations to vital data for every record before granting final approval to the record. Audit trails that necessitate consistent reviews should encompass various aspects, such as: Modification history of test results for finished products Amendments to sample run sequences Revisions to sample identification and significant alterations to process parameters To ensure effective oversight, the FDA advocates for scheduled, routine audit trail evaluations, which should be determined based on factors like the system’s complexity and its designated purpose. 4. Who should review audit trails? Audit trails are integral components of the correlated records. Those tasked with reviewing records in accordance with CGMP should concurrently examine the audit trails that document modifications to vital data linked with the record. To illustrate, the quality unit is responsible for scrutinizing and endorsing all production and control records, encompassing audit trails. This parallels the anticipation that handwritten alterations on paper records should be evaluated during data reviews. 5. Can electronic copies be used as accurate reproductions of paper or electronic records?  Certainly, electronic duplicates can function as authentic replicas of paper or electronic records, assuming they retain the substance and significance of the initial data, encompassing linked metadata and the constant or fluctuating attributes of the original records. For dynamic electronic records, authentic reproductions may be generated and upheld in either the original or a compatible format, contingent upon the conservation of the content and meaning of the primary records. Appropriate reader and copying equipment (such as software, hardware, and media readers) must remain conveniently accessible. Note: “Static” denotes an unchanging data document, such as a paper-based record or an electronic image. In contrast, “dynamic” refers to a record format that enables interaction between the user and the record’s content. For instance, a dynamic chromatographic record might permit the user to alter the baseline and reprocess chromatographic data, potentially causing adjustments in the appearance of resulting peaks. Additionally, it might enable users to amend formulas or input within a spreadsheet used for calculating test outcomes or other data, such as calculated yields. 6. When does electronic data become a CGMP record? When data is generated to meet CGMP requirements, it becomes a CGMP record. It’s important to save or document this data during creation, following CGMP rules. Quality data must not be changed, so processes should ensure that. For example, save chromatograms right after a run. Using temporary paper or storing data electronically manipulably isn’t allowed. Use a mix of technical and procedural controls. Computer systems like LIMS can auto-save after each entry, like recording on paper. This keeps CGMP practices intact. 7. How does FDA recommend data integrity problems identified during inspections, in warning letters or other regulatory actions be addressed?  FDA advises demonstrating effective problem resolution by: Engaging a third-party auditor. Identifying the issue’s extent. Executing a global corrective action plan. Replacing those responsible for problems in CGMP roles. FDA could inspect to confirm data integrity CGMP violations are resolved. These align with Application Integrity Policy standards. For detailed guidance, refer to the “Points to Consider for Internal Reviews and Corrective Action Operating Plans” public document on the FDA website. Schedule a Free Consultation

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eQMS
April 10, 2023

Unveiling the 8 Benefits of Quality Management Software in Pharma

As manufacturers in the pharmaceutical industry face new-market demands, intricate supply chains, and evolving regulations, there is a growing need to reassess outdated and disconnected systems and processes. These disconnected systems create gaps between manufacturing and quality management, making it difficult to keep up with rapidly changing regulations and meet time-to-market goals. So, how can pharma manufacturing become more agile, data-driven, and future-ready? To address these challenges and ensure future readiness, pharma manufacturing must undergo digital transformation. By embracing electronic quality management software(eQMS), manufacturers can enhance agility and collaboration throughout the supply chain to meet the ever-changing market demands. Leveraging technologies such as cloud computing, artificial intelligence, and the Internet of Things (IoT), manufacturers can seamlessly scale operations to accommodate new therapies like precision medicine. Furthermore, mobile devices with cloud applications enable operators to access real-time, up-to-date content. However electronic quality management software streamlines discrete quality processes, supplying the necessary flexibility across the product lifecycle, from clinical to commercial stages. For instance, integrating standard operating procedure (SOP) management with training assignments and delivery facilitates automated training based on specific versions, leading to faster qualification times. Therefore, by embracing eQMS software, pharmaceutical manufacturers can overcome the challenges posed by dynamic market conditions, complex supply chains, and regulatory changes. This transformation enables them to adapt quickly, leverage data-driven insights, and achieve increased collaboration and operational efficiency. Ultimately, digitalization paves the way for a future-ready and agile pharmaceutical manufacturing industry. This article explores eight critical benefits of pharma quality management software in the pharmaceutical industry. Here are 8 Benefits of eQMS Software in Pharma 1. Regulatory Compliance: The pharmaceutical industry is heavily regulated, with strict guidelines and standards set by authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A well-implemented QMS helps pharmaceutical companies ensure compliance with these regulations, reducing the risk of penalties, regulatory sanctions, and product recalls. By adhering to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP), companies can maintain their licenses and uphold the safety and efficacy of their products.  2. Enhanced Product Quality: Quality is paramount in the pharmaceutical industry, where patient safety and health outcomes are at stake. A QMS Software establishes robust quality control processes that consistently deliver high-quality products. By implementing standardized procedures, rigorous testing protocols, and comprehensive quality checks, pharmaceutical companies can reduce the likelihood of product defects, contamination, and adverse events. As a result, it instills confidence in healthcare professionals and patients regarding the reliability and effectiveness of the medications they prescribe or consume. 3. Patient Safety: Ensuring patient safety is a top priority for the pharmaceutical industry. A well-implemented eQMS software contributes significantly to this objective. By implementing stringent quality control measures, risk assessments, and comprehensive safety protocols, pharmaceutical companies can identify and mitigate potential risks to patient safety. This includes monitoring the manufacturing processes, analyzing adverse event data, and implementing appropriate corrective actions to prevent patient harm. It helps build trust and confidence among patients, knowing that the medications they rely on are produced and monitored with the utmost care. 4. Streamlined Operations: Efficient and streamlined operations are vital for pharmaceutical companies to meet market demands, maintain competitiveness, and optimize resource utilization. An eQMS software provides a framework for process optimization, eliminating inefficiencies, and reducing waste. By implementing standardized procedures and workflows, companies can streamline manufacturing, testing, and distribution processes, thereby minimizing errors, delays, and costs. This ultimately leads to increased productivity, improved operational efficiency, and better resource allocation. 5. Risk Mitigation and Management: The pharmaceutical industry is exposed to various risks, including supply chain disruptions, regulatory non-compliance, product recalls, and adverse events. It helps companies proactively identify, assess, and mitigate these risks. By implementing risk management processes and conducting thorough risk assessments, pharmaceutical companies can minimize the likelihood and impact of potential risks. This includes monitoring and auditing suppliers, conducting regular inspections, and implementing appropriate corrective and preventive actions. By managing risks effectively, companies can safeguard their operations, reputation, and patient well-being. 6. Continuous Improvement: Continuous improvement is a core principle of quality management systems. It provides a structured framework for monitoring, measuring, and analyzing key performance indicators (KPIs). By conducting regular audits, reviews, and feedback loops, pharmaceutical companies can identify areas for improvement and implement corrective actions. Continuous improvement can encompass various aspects, including process optimization, employee training, supplier qualification, and customer feedback integration. By fostering a culture of continuous improvement, pharmaceutical companies can enhance their overall performance, meet evolving market demands, and drive innovation. 7. Supplier Relationships: Strong relationships with suppliers are crucial for maintaining the integrity and quality of pharmaceutical products. It helps companies establish robust supplier qualification and monitoring processes. Thereby implementing stringent criteria, evaluating supplier performance, and conducting audits, pharmaceutical companies can select reliable partners who meet the required quality standards and regulatory obligations. Strong supplier relationships enable a secure supply chain, reduce the risk of counterfeit or substandard materials, and facilitate efficient collaboration and communication. 8. Enhanced Reputation and Customer Trust: Building and maintaining a strong reputation is vital for success in the pharmaceutical industry. A well-implemented eQMS software contributes to a positive brand image by consistently delivering high-quality products, ensuring regulatory compliance, and prioritizing patient safety. By demonstrating a commitment to quality through the implementation of robust processes, thorough testing, and adherence to industry standards, pharmaceutical companies can build trust and credibility among healthcare professionals, patients, and regulatory authorities. Simultaneously can lead to increased market share, customer loyalty, and sustained business growth. The Future of quality management Transforming quality management is vital to successfully gaining the agility needed to produce new therapies. Amplelogic’s integrated solutions emphasize flexibility and efficiency, positioning manufacturers to reap immense benefits in simplifying and improving quality management. Eliminating siloed systems in favour of streamlined solutions permits greater agility and stronger collaboration while enhancing compliance and end-to-end control. It enables life-science manufacturing industries to meet the new demands of quality management and support innovation in precision medicine. Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint

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April 10, 2023

Compliance with Schedule M of the Drugs and Cosmetics Act (2018)

In a recent announcement, Health Minister Mansukh Mandaviya emphasized the importance of complying with Schedule M of the Drugs and Cosmetics Act, prepared in 2018. A Pharma company with a turnover of less than Rs 250 crore will have to adopt GMP regulations in a 12-month time, and those with over Rs 250 cr turnover must have GMP adoptions within 6 months. The schedule outlines crucial guidelines for all the Organizations manufacturing drugs may be Pharmaceutical, Biotech, Therapeutics, and CROs must comply with Schedule M automation. However, non-compliance with the stipulated timelines could lead to penalties as per the provisions of the law. Also, the most significant gap found in the industry is the Linkage between manufacturing and product quality, and interdependence between the two has been established. Understanding Schedule M Schedule M delves into various aspects of company premises, quality control systems, laboratories, GMP adoption in production, equipment cleaning, housekeeping, and cross-contamination. Organizations involved in drug manufacturing must adhere to these guidelines for maintaining high-quality standards. Implementing Schedule M Automation in Organizations Compliance with Schedule M demands a coordinated effort across different departments, including Production, Engineering, Quality Control, Quality Assurance, and Warehouse. Many small and medium-sized organizations manage these activities manually, leading to potential compliance issues like GMP regulations. Challenges Faced by Small and Medium Enterprises Even with stringent processes, human error can still lead to compliance challenges. Moreover, implementing automation systems demands a considerable budget and skilled talent, which might only be readily available to some enterprises. How do we link between manufacturing and product quality and interdependence? Organizations can leverage cost-effective integrated software to bridge the manufacturing and product quality gap. These systems include: ERP: For comprehensive management of procurement, inventory, and sales processes. LIMS: To streamline laboratory quality control procedures. eQMS with RTM: For automating deviations, CAPA (Corrective and Preventive Actions), change control, and audits in the quality assurance department. eDMS: To automate version control and print management of SOPs, protocols, specifications, and more across all departments. eLMS: For efficient management of training processes throughout the organization. eBMR (MES): To handle batch manufacturing information effectively. eLog Book: For recording operational and cleaning activities in operations. APQR: For automated product quality report generation based on integrated software data. RIMS: To track regulatory application statuses from filing to retirement. Calibration and PM: The engineering department can manage assets in compliance with guidelines set forth by the schedule. Pharma automation companies like Amplelogic help in the current timebound scenarios Amplelogic can play a pivotal role in the timely implementation of automation solutions. With over 13 years of experience delivering automation software for Drug Product and Drug substance organizations, Amplelogic offers ready-to-use software that can be swiftly implemented. The implementation timelines can be tailored within 1 to 3 months, depending on the scope. Conclusion Compliance with Schedule M is a crucial aspect of the pharmaceutical industry. Embracing automation and integrated software can help organizations, especially small and medium enterprises, overcome compliance challenges and achieve seamless adherence to Schedule M automation, ultimately enhancing product quality and patient safety. Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom (UK)United States (US)United States (US) Minor Outlying IslandsUnited States (US) Virgin IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabweSource– Select –Google SearchLinkedInReferralWord of MouthLinkedIn AdsMediumRequirementGet in touch

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April 7, 2023

7 Common Compliance Issues Faced by the Pharmaceutical Industry

The pharmaceutical industry is critical in safeguarding public health by researching, developing, and manufacturing life-saving drugs. However, this sector operates in a highly regulated environment due to the potential risks associated with drug production and distribution. Compliance with regulatory standards is vital to ensure patient safety and maintain the industry’s integrity. This article will explore 7 common compliance issues the pharmaceutical industry encounters and discuss their implications. Good Manufacturing Practices (GMP) Violations: One of the most significant compliance challenges is adhering to Good Manufacturing Practices. GMP violations can contain inadequate quality control, inappropriate documentation, and failure to follow standard operating procedures. Such breaches can lead to product recalls, fines, and damage to a company’s reputation. Data Integrity: Data integrity is crucial for maintaining pharmaceutical records’ accuracy, completeness, and consistency. Compliance issues occur when companies fail to establish robust data management systems, leading to data manipulation, unauthorized access, or data loss. These breaches can harm product quality, clinical trials, and regulatory submissions. Adverse Event Reporting: Pharmaceutical companies must report any adverse events associated with their products promptly. Compliance issues arise when companies fail to identify and report adverse events within the required timeframes. Inadequate adverse event reporting not only poses risks to patients but also undermines the pharmaceutical industry’s transparency and credibility. Supply Chain Compliance: The pharmaceutical supply chain is complex, involving numerous stakeholders, including manufacturers, distributors, and pharmacies. Ensuring compliance across the supply chain can be challenging, especially when dealing with counterfeit drugs, unauthorized distribution, or improper handling and storage of pharmaceutical products. Failure to maintain supply chain compliance can lead to substandard or counterfeit drugs reaching patients. Fraud and Corruption: The pharmaceutical industry meets risks related to fraud and corruption, such as illegal kickbacks, off-label promotion, and bribery. Unethical practices can compromise patient safety and distort fair competition. Compliance issues in this area can result in severe legal consequences, damage to a company’s reputation, and financial losses. Intellectual Property Protection: Intellectual property (IP) is the cornerstone of innovation in the pharmaceutical industry. Compliance challenges arise when companies fail to adequately protect their IP rights or engage in patent infringement. IP non-compliance can hinder innovation, discourage investments, and lead to costly legal battles. Regulatory Compliance in Research and Development: Pharmaceutical companies must comply with regulations throughout the research and development (R&D) process. Failure to follow ethical guidelines, obtain proper participant consent, or accurately report clinical trial results can result in compliance issues. Non-compliance in R&D can delay drug approvals, harm patient safety, and damage a company’s reputation. Wrap up Compliance issues in the pharmaceutical industry are multifaceted and can have far-reaching consequences. To mitigate these challenges, pharmaceutical companies must prioritize compliance by implementing robust quality systems, data management protocols, and supply chain controls. A proactive approach to compliance ensures patient safety, strengthens trust in the industry, fosters innovation, and paves the way for the development of life-saving drugs.  Likewise, Amplelogic is the First Low Code driven product company for life sciences. It speeds up compliance and quality assurance with integrated solutions to the pharma business process. Moreover, it includes 18+ COTS products compliant with 18+ products like eQMS, LMS, DMS, eLogs, Calibration Schedules, Stability, APQR, and more, serving 100+ Pharma companies worldwide. Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom (UK)United States (US)United States (US) Minor Outlying IslandsUnited States (US) Virgin IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabweWhere you heard about us?– Select –Google SearchLinkedInReferralWord of MouthLinkedIn AdsMediumRequirementGet in touch

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March 21, 2023

Pharma 4.0 Adoption in India: A Catalyst for Modernization in the Pharmaceutical

As the Indian pharma sector embraces digitalization and advanced technologies, several key transformations are expected: 1. Global Competitiveness: By going digital and incorporating Pharma 4.0, Indian pharmaceutical companies can enhance their global competitiveness by being at the forefront of technological innovation and efficiency. 2. Regulatory Compliance: Implementing Pharma 4.0 technologies helps streamline regulatory compliance, making audits and inspections smoother and more efficient. 3. Continuous Manufacturing: Pharma 4.0 facilitates continuous manufacturing processes, enabling seamless production with reduced downtime. This approach increases efficiency and reduces waste. 4. Accelerated Drug Discovery: Advanced computational methods and machine learning algorithms can analyze vast amounts of data, accelerating drug discovery and reducing the time required to bring new drugs to market. 5. Real-time Monitoring and Control: Pharmaceutical companies can monitor manufacturing processes and critical parameters in real-time with IoT and data analytics. This proactive approach allows for early detection of deviations and immediate corrective actions. Also check – How can Pharma companies stay in control of their QMS? To sustain this progress, the industry must focus on several key areas: 1. Enhanced Communication: Establishing a direct shop floor to higher management connectivity ensures seamless collaboration. 2. Paperless Operations: Minimizing paper usage mitigates data integrity risks and ensures compliance. 3. Investing in Quality: Increasing the quality budget fortifies a commitment to excellence. 4. Embracing Emerging Technologies: Adapting to emerging technologies fosters innovation and efficiency. 5. Continuous Improvement: Pursuing a culture of continuous improvement drives progress and quality enhancement. 6. Patient-Centric Approach: Prioritizing patient needs promotes better healthcare outcomes. 7. Regulatory Compliance: Upholding compliance standards is crucial for sustained growth. Digital transformation is the key to future success, enabling the Indian pharmaceutical industry to navigate the evolving global landscape. By embracing innovation, fostering regulatory excellence, and investing in technology, the industry can confidently embrace a brighter future. As we reflect on the future, we invite our readers to share their thoughts on the industry’s challenges and opportunities. The impact of digitalization on drug development, manufacturing, and patient care is an important conversation. We welcome your insights and queries, and together, we can drive the Indian pharmaceutical industry towards a prosperous tomorrow. –Vijay Patil, Product Manager – AmpleLogic Empowering the future of pharma through digitalization, innovation and reshaping the processes” Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom (UK)United States (US)United States (US) Minor Outlying IslandsUnited States (US) Virgin IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabweWhere you heard about us?– Select –Google SearchLinkedInReferralWord of MouthLinkedIn AdsMediumRequirementGet in touch

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March 20, 2023

Are Your Logbooks in Place For The Upcoming Audit?

As a pharmaceutical manufacturer, you are likely familiar with the stringent regulatory requirements governing the industry. One critical aspect of compliance is o maintain accurate and up-to-date records and documentation. But have you considered the role of logbooks in your record-keeping system? If not, you may want to start. Manufacturing Logbooks are vital records that document critical information related to drug development, manufacturing, and distribution. They provide a written record of activities and events, serving as a valuable tool for compliance, quality control, and troubleshooting. The FDA requires that pharmaceutical manufacturers maintain detailed logs of various activities, including equipment maintenance, calibration, and cleaning, as well as environmental monitoring, product testing, and batch records. These logbooks are subject to inspection by FDA inspectors during routine inspections or in response to adverse events or quality issues. In addition to regulatory compliance, logbooks play a crucial role in ensuring product quality and safety. They provide a means of tracking trends and identifying potential issues before they become significant problems. For example, if a batch of product fails testing, a review of the relevant logbooks can help identify the cause of the issue, allowing for corrective action to be taken. What challenges are Pharma Companies facing with logbooks? Pharmaceutical manufacturing and processing operations often rely on paper-based logbooks to record critical information related to their activities. While paper logbooks have been a standard record-keeping practice for many years, they pose several challenges, including: 1. Inaccuracy: Paper-based logbooks are prone to errors and inaccuracies, such as incomplete entries, illegible handwriting, and incorrect information. These errors can compromise the integrity of the data and lead to regulatory non-compliance. 2. Time-consuming: Maintaining paper logbooks is a time-consuming process that requires significant effort and resources. Entries must be made manually, and multiple logbooks need to be cross-referenced to ensure accuracy. 3. Storage: Storing and archiving paper logbooks can be a significant challenge, especially in facilities where space is limited. Additionally, if logbooks are not properly stored or archived, the data may be lost, making it difficult to trace back activities and events. 4. Accessibility Retrieving data from paper logbooks can be a slow and tedious process, especially if the data is spread across multiple logbooks. This can make it difficult to identify trends, patterns, and potential issues, ultimately impacting decision-making processes. 5. Security Paper logbooks are susceptible to tampering, loss, or theft, compromising the confidentiality and integrity of the data. Without adequate security measures, unauthorized access to logbooks can put sensitive information at risk. Given these challenges, many pharmaceutical companies are transitioning to electronic logbook systems. Electronic logbooks offer several advantages, including improved accuracy, ease of use, accessibility, and security. They provide real-time data entry and retrieval capabilities, automated data validation, and analytics, streamlining the record-keeping process and improving overall data quality. How can Digital Logbook help Pharma Companies? One way that pharmaceutical companies can achieve this is by utilizing the Electronic Logbook Solution. Digital eLogs software is an electronic record-keeping system that can help pharma companies to manage their processes, track data, and maintain regulatory compliance. Here are some of the ways that eLogbook software can help pharmaceutical companies: 1. Data Management: One of the primary benefits of eLogbook software is that it helps pharmaceutical companies manage their data more efficiently. With the ability to track and record data electronically, companies can quickly and easily access the information they need, saving time and improving accuracy. The eLogs software also allows for easy data analysis and reporting, which can help companies make more informed decisions. 2. Regulatory Compliance: Pharmaceutical companies are subject to strict regulations, and eLogbook software can help them maintain compliance. The software allows companies to track and document all activities and transactions, ensuring that they meet regulatory requirements. E-Log Management Solution can also help companies prepare for audits and inspections by providing a complete audit trail of all activities. 3. Improved Efficiency: Digital Logbook Software can help pharmaceutical companies to improve their efficiency by automating many tasks. For example, the software can automatically generate reports, track inventory, and monitor equipment maintenance. This can help companies to save time and reduce errors, allowing them to focus on more critical tasks. 4. Increased Collaboration: Paperless Logbook software allows for real-time collaboration between team members, regardless of location. This can help companies to work more efficiently and effectively, enabling them to respond to challenges more quickly. The software also allows for easy communication between departments, improving communication and teamwork. 5. Cost Savings: By streamlining processes and improving efficiency, Electronic Equipment Logbook software can help pharmaceutical companies to save money. The software can help companies to reduce errors, minimize downtime, and improve productivity, all of which can result in significant cost savings. In conclusion, while paper-based logbooks have been a traditional record-keeping practice in the pharmaceutical industry, they pose several challenges that can impact data accuracy, accessibility, and security. By transitioning to electronic logbook systems, pharmaceutical companies can overcome these challenges and achieve greater efficiency, compliance, and data integrity. So, logbooks are an essential component of any pharmaceutical manufacturing or processing operation. They provide a written record of critical activities and events, ensuring compliance with regulatory requirements and facilitating quality control and troubleshooting. So, the next time the FDA calls, you can rest assured that your logbooks are in place and up to date. Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and

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March 20, 2023

8 Important KPI’s for Quality Management System

Key Performance Indicators (KPIs) are critical metrics that are used to measure the performance of a Quality Management System (QMS). They provide insight into how well the QMS is meeting its objectives and goals. By monitoring KPIs, organizations can identify areas for improvement, make informed decisions, and continuously improve the quality of their products or services. Some common KPIs used in QMS include customer satisfaction index, defect rate, on-time delivery, and process efficiency. Here are 8 Important KPI’s for Quality Management System 1. Customer complaintsCustomer complaints are an essential part of any Quality Management System (QMS). They provide valuable feedback about the organization’s products or services, which can be used to identify areas for improvement and prevent future customer complaints. 2. Customer Satisfaction Index (CSI)The Customer Satisfaction Index (CSI) is a metric used to measure how satisfied customers are with a company’s products, services, or overall experience. CSI is expressed as a percentage, with 100% being the highest level of satisfaction. 3. Defect RateDefect rate is a metric used to measure the quality of products in the pharmaceutical industry. It refers to the percentage of defective products that do not meet the established quality standards. Defective products may pose a risk to patient safety or be ineffective in treating the intended disease. 4. Risk ManagementRisk management is a critical process in the pharmaceutical industry that involves identifying, assessing, and mitigating risks associated with the development, manufacturing, and distribution of pharmaceutical products. The goal of risk management in pharma companies is to minimize the potential harm that could be caused to patients and users of the products. 5. Overdue issuesOverdue issues KPI is used to measure the efficiency and effectiveness of their operations. It refers to the number of tasks or activities that are not completed within the designated time frame or deadline. 6. Rework CostsIn pharmaceutical companies, rework costs can be a significant drain on resources. Rework refers to any activity that is performed after a product has been completed, in order to fix defects or improve quality. These activities can include reprocessing, repackaging, re-labelling, and more. 7. Supplier QualitySupplier Quality Key KPI is a metric used to measure the quality and reliability of their suppliers. Suppliers play a critical role in the pharmaceutical industry as they provide raw materials, components, and services that are essential to the manufacturing and distribution of pharmaceutical products. 8. Warranty Claims RateWarranty Claims Rate KPI is used to measure the quality and reliability of their products. It refers to the percentage of products that are returned or repaired under warranty due to defects or failures. Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom (UK)United States (US)United States (US) Minor Outlying IslandsUnited States (US) Virgin IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabweWhere you heard about us?– Select –Google SearchLinkedInReferralWord of MouthLinkedIn AdsMediumRequirementGet in touch

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March 20, 2023

Harmonizing Voluminous Logbooks eases Record Keeping in the Pharmaceutical Industry

The global pharmaceutical industry has boomed for decades by increasing its market in both the developed and the developing nation. With the evolution of data- and technology-driven changes it has transformed the industry, pharmaceutical companies and being forced to revamp their existing strategies. The emerging markets are becoming more complicated for pharmaceutical companies, making the commercial atmosphere tough and harder for them to sustain. Amidst all the changes, one of the biggest challenges encountered by pharmaceutical players is shifting from their traditional manual log book to digital log book. Most pharma formulations and chemical manufacturing sites record the operations details in paper-based instrument/ equipment usage logbook. Depending on the dimension of the organizations, they record information in huge logbooks. In addition, the logbooks maintained by the organizations range from 500-2000, containing multiple product categories. It is often observed that keeping track and updating the manual logbook and their version is a monotonous job. However, there are higher chances of duplicating the information which can lead to regulatory issues. Let’s go through few challenges encountered by the organization: Challenges of existing Manual Logbooks in Pharmaceutical Industries Compliance and regulatory challenges: Maintaining manual logbooks demands immense paperwork and manual entries, which can be prone to human errors and mistakes. Hence leading to compliance and regulatory issues, including fines and penalties. Productivity and efficiency issues: Manual logbooks can be time-consuming and labour-intensive, demanding much effort and resources to maintain and update. Therefore, the consequence results in productivity and efficiency. Data accuracy and consistency: It is often maintained by different individuals, utilising different formats and styles, leading to inconsistencies and errors in the data. It can extract meaningful insights and trends from the data complex. Inventory Management: For pharma companies keeping track of their inventory, meeting constantly changing regulations, supplying promising solutions with the utmost quality, and balancing risks associated with inventory shortages and gluts is very challenging. Risk Management: Managing risks in drug development and discovery are of extreme importance. Every product and process are exposed to risk, making it important for companies to reduce risks, which can threaten the quality of their products. Now that we know about the challenges. Let’s see the multiple log book maintained by the manufacturing area followed by engineering, plant maintenance warehouse and more. To name a few logbooks Area cleaning Record Preparation & Usage of Disinfectant solution record Washing area cleaning Record Calibration test record Area sequential log Equipment/Instrument Sequential Log While looking at the above example logs, even though the process is the same, organizations still maintain different log formats for each facility due to manually printed logbooks. According to the experts, out of 1000+ logbooks, nearly 60% of logbooks are required to be recorded daily, remaining weekly, monthly, quarterly and once in 6 months. Digitalization of LogBooks The term “digitalization of logbooks” is the game changer for all the organizations using manual logs. It substitutes the traditional ones to eliminate duplication and manipulation. It can only be successful once digitalization of these manual logbook organizations and their technology partners must land on the same page to finalize the scope by harmonizing the existing log books. The objective of this partnership is to eliminate the duplication in the current manual logs. Let’s see the perk of digital logs below: Real-time monitoring and reporting: Digital log book supply real-time monitoring and reporting of operations, enabling organizations to identify and address issues quickly. It enhances the quality of products and reduces the risk of product recalls. Data analytics and insights: It offers rich data analytics and insights, enabling organizations to determine trends and patterns in operations, optimize processes, and enhance overall efficiency and productivity. Collaboration and communication: Fosters collaboration and communication between departments and stakeholders. Hence, they can share information and insights and work together more effectively. Cost savings: Help organizations save costs by reducing the need for paper-based records, streamlining operations, and improving overall efficiency and productivity. By addressing these challenges and leveraging the benefits of digital logbook, pharmaceutical organizations can improve their operations, increase productivity and efficiency, and ensure compliance and regulatory compliance. The road ahead Looking at the existing diverse logs makes the Project look huge, but nearly 80 harmonized electronic log book can handle nearly 90% of the daily and weekly usage logs. In case of Organizations with more than 10 Sites and multiple product types they can follow the below defined stage wise approach for the Results. While defining these logs, business users must consider offline logbooks where network connectivity is a big challenge, especially in aseptic areas. In the world of digitalization, it’s high time for your business to step up and go hassle-free to stay ahead in the market. Author : Manne V Chowdary, Being CEO and Founder at Amplelogic Mr. Manne Associated with 100+ Life science Organizations in creating and executing their Digital Roadmaps. Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom (UK)United States (US)United States (US) Minor Outlying IslandsUnited States (US) Virgin IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabweWhere you heard about us?– Select –Google SearchLinkedInReferralWord of MouthLinkedIn AdsMediumRequirementGet in touch

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March 20, 2023

Implementing Time and Content Validation with Learning Management Software

The growing favour of e-learning through LMS Software earned friction across various businesses, particularly pharmaceutical firms. It’s one of the vital sectors in the European and other economies. After the pandemic, healthcare and vaccination became the top priority of every country. However, it was the same for other medicines as well in the market. On the other hand, the pharmaceutical LMS plays a critical role in training more personnel and offering them certificates. Due to this rapid growth in the pharmaceutical industry, more workforce is demanded. According to the Markets and Markets reports, during the projected period. “The LMS market is predicted to shoot from USD 9.2 billion in 2018 to USD 22.4 billion in 2023, with a Compound Annual Growth Rate (CAGR) of 19.6%.” Even though many firms appreciated LMS for pharma but still lacked in some areas. The ground reality Although the learning management software for pharma has significantly enhanced training processes. But few emerging challenges have surfaced regarding users completing training without fully reading the content of standard operating procedures (SOPs). In other words, the conventional completion of SOP training demands users to invest a specific minimum duration, typically 30 to 40 minutes, to ensure thorough understanding and compliance. However, users have ignored this requirement, completing the training within 2 to 3 minutes. As a result, this behaviour poses significant compliance risks indicating insufficient time spent on critical SOP content. This article presents a solution to address this compliance issue by implementing time and content validation features in the digital learning management system. 1. Time Validation: Administrators must specify a minimum duration for each material when devising training materials. This duration defines the recommended time for users to get a brief understanding of the content thoroughly. When a user is allocated the training, the system ensures that the specified timing is met before allowing completion. Users must engage with the material for a specific duration, averting sudden completion and encouraging a more comprehensive understanding of the SOP. 2. Content Validation: In addition to time validation, the pharma LMS software incorporates content validation to ensure users have completed the training material. The system tracks user progress and validates whether they have reviewed all sections of the SOP. Users must display knowledge of the complete content before being allowed to complete the training. This approach ensures that critical information is not overlooked or neglected, reducing compliance risks and enhancing overall training effectiveness. Endless perks in one place! Thereby implementing time and content validation in LMS Software for pharma welcomes multiple advantages and impacts the pharmaceutical industry. Let us have a look below: 1. Enhanced Compliance: By implementing the specified minimum duration and content validation, the application confirms that users spend adequate time on SOP training, eliminating compliance issues and risks associated with incomplete or rushed understanding. 2. Improves Training Quality: The solution facilitates a comprehensive understanding of SOPs by encouraging users to engage with the training material for the recommended duration. This results in higher training quality, better retention of critical information, and enhanced application of SOPs in real-world scenarios. 3. Audit Readiness: The LMS for pharma delivers a robust mechanism for organizations to exhibit their commitment to compliance during audits. The system tracks and records user engagement, providing a reliable audit trail and evidence of thorough training completion. 4. Efficient Resource Utilization: Organizations can allocate resources more efficiently by ensuring that users spend an adequate duration on training, focusing on other critical tasks and initiatives. Summing up The essence of pharma learning management software can be described better with the company’s training and development plans. A recent study indicates that 60% of pharmaceutical companies have already started to rely more on LMS for the flexibility and the value it adds to training their employees. It enables pharma companies to develop even further without consuming more time and money on different departments, however small or big the companies are. “In 2020, 7% of the healthcare and pharmaceutical industries have trained employees in LMS.” Amplelogic LMS software for pharma implements time and content validation to offer a robust solution to the compliance issues arising from users completing SOP training without fully reading the content. By mandating minimum duration requirements and validating content engagement, the application promotes comprehensive understanding, enhances compliance, and provides organisations with an audit-ready training framework. With this solution in place, pharmaceutical companies can confidently ensure that employees receive thorough and adequate training on standard operating procedures. Author: Ajith Kumar: Experienced Business Analyst and Database Developer – Delivering Cost-Effective Solutions and Streamlining Processes for Pharma Training Compliance with Amplelogic’s LMS Solution Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom (UK)United States (US)United States (US) Minor Outlying IslandsUnited States (US) Virgin IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabweWhere you heard about us?– Select –Google SearchLinkedInReferralWord of MouthLinkedIn AdsMediumRequirementGet in touch

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cloud software devlopment
March 20, 2023

Document Management Systems is a boon to the Topical Pharmaceutical Sectors

Incorporating new-age technology in Lifesciences: With digitalization in impact there has been a lot of astounding changes in every industrial sector including pharma and life sciences companies. When practically we have uncovered countless benefits of this new age inculcation in the global market, we also cannot walk away from the fact that digitalization has also disrupted industries on various other levels. With this we conclude that every innovation comes with certain pros and cons! But humans have always found out ways to deal with the harsh part of any innovation and so they have dealt with this too. Keeping customer satisfaction and business extension at the forefront, contemporary pharma industries have started adopting digitalization trends in their manufacturing as well as operation and document management system is one among many. With this, automatic integration of all the document-related activities of a pharma sector has been way easier & simpler. Transforming paper-based activities to automatic paper-less ones smoothly with less cost consumption is the whole-sole intention behind this digital trend in pharma companies. DMS: Get it transformed from Manual to Automatic Pharmaceutical industries go through a huge number of paper activities every day and to manage them there is a high requirement of resources. But, with manual interferences there is a quite good chance of information mismatch, incorrect feeding, untimely delivery, etc. Whereas with DMS or Document Management Systems, all these activities can be handled easily without any manual activities. Whatever is the phase of the entire pharmacy function, on every stage there is a big need of maintaining all the informative documents safely, so that they can be accessed whenever required without any hassle. In a way, DMS has contributed a lot to the content management activities encompassing all the electronic data like emails, batch records, quality control records, crucial regulatory details, etc. Instead of creating a pile of informative files manually one after another, through the Electronic Document Tracking System one can easily find all the important data stored in one place accessible from anywhere. Besides, FDA’s 21CFR Part 11 compliance says that it has been mandatory for all the organizations to replace their paper-based documents and signatures with electronic records and e-signatures. Aiming to better the document maintenance of the pharma companies, AmpleLogic is also encouraging life sciences industries to introduce eDMS into their business activities and attain a tag of paperless company. Using Document Management Systems, a lot of things can be handled efficiently in a specified manner and many challenges faced by Lifesciences industries can be tackled easily. Sort of difficulties industries face these days with manual activities in pharma industries are: Excessive Time Consumption: because of paper-based activities, one channel stays dependent on the other every phase, which consumes a lot time. besides, it hampers streamline planned for project. with document manager, this whole manual set-up can be processed smoothly and automatically without any hassle. Probability of Errors: When the whole documentation is managed manually, there is a huge probability of misplacement of documents. With this, it becomes difficult to get the accurate document or data whenever required. Poor Tracking Activities: It becomes difficult to keep a tab on the tracking activities of various regulations being updated in several pharmaceutical industries. Lagging on training the resources: With DMS software, it becomes easy to integrate learning management systems (LMS) with the documents, automatically. When these things are done manually, then it lacks integration and resources are not being intimated about the trainings to be taken as per their domain and skills. Last-minute rush: With many things altogether, it is tough to memorize a few revisions work, which can be done easily using eDMS. It will intimate users with automatic notifications, reminders, escalations, etc. without any miss, so that things can be done before the deadline. Inefficient collaboration: In manual document management it becomes tough to collaborate various departments like operation, production,quality assurance, engineering, etc. in a perfect streamline, which can be accomplished using DMS. Unsecured data storage: Keeping a stack of paper-based documents in a physical storage could be dangerous when they face unprecedented accidents like fire or anything. Why not use a secured cloud for orderly document control? When there has been an inevitable need to consolidate digitalization to the contemporary life sciences industries, then we must consider the Document Management Systems as the very first trend to bring in. Understanding the benefits of eDMS, AmpleLogic is assisting various pharmaceutical companies around the globe to add this seamless and cost-effective integration to their business. We would like to resolve all your queries on DMS, reach us for a quick demonstration. Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom (UK)United States (US)United States (US) Minor Outlying IslandsUnited States (US) Virgin IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabweWhere you heard about us?– Select –Google SearchLinkedInReferralWord of MouthLinkedIn AdsMediumRequirementGet in touch

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March 20, 2023

Tweaking V Model to Accelerate GMP Automation’s and Address Data Integrity Issues

A long list of data integrity warnings received by pharma companies has made them train their focus on building and fortifying their tracking mechanisms to prevent things from going wrong. One of the solutions is digitization and building a data repository to make it easily available to analyze issues and predict challenges. However, the current challenge is that the digital transformation is going slower than expected, resulting in the engagement of quality resources for a longer time. Implementation of pre-validated software’s like LIMS, DMS, QMS, LMS are taking longer than 12 months and electronic batch manufacturing records (eBMR) are taking more than three years. Most implementations are going beyond the scheduled time due to rework and mid-way requirement changes. This impacts all the documents and hence requires repeated updations with the latest changes. These complications should be addressed with smooth and flexible methods. In general, the OQ duration is 60 percent of the total effort of a project. It is questionable whether such an effort is constructive for configurable software packages (GAMP category 4 & 5). Even after investing a good amount of money and resources, they are not able to realize the expected outcomes. Key challenges On the pharma industry front Business user requirements are not documented properly Unstable senior management. Functional requirements are not detailed enough and do not have traceability to user requirements Very expensive change request. (Cost of change) Traceability matrix is not maintained or updated On the supplier front Rigid systems (Need to write code for every major change) Lack of domain knowledge and unskilled programmers Traditional software implementation methodologies V Model: Verification and Validation Model Most of the software implementations in the pharma industry will follow this model. The success of the V Model is when requirements are well defined with no ambiguity and acceptance criteria well defined. In the V Model, there are long cycle times from user requirement specification to user acceptance test and requirements may change in the meantime. The modeling of user requirements without seeing a running piece of software is abstract and usually, requirements for modification arise when the final user deals with the running software for the first time. The traditional V model software implementation methodologies will not create an interest among the business teams as it takes longer to address a change. If any changes happen midway, then the test documents, along with requirement documents, have to be updated. The cost of major change/ requirement gaps realized in the OQ stage will turn out to be very expensive and delays the validation process. From the past 10 years, regulatory inspections focus more on software and computer system validation. Deviations have been cited across all steps of computer validation from writing specification and risk assessment to IQ/OQ/PQ, revalidation, reporting, and change control. The traditional V Model: It must be revisited based on our real-time experiences One important aspect is the Configuration and Experimentation phase. The introduction of this phase in between the User Requirement Specification and Functional Requirement Specification of the V model will help the business users in understanding the pre-validated software and relating the software with his problem statement. This approach helps in realizing the requirements before the finalization of functional requirement specifications. The business user’s clear on the software outcome. Adding the Configuration and Experimentation phase in the implementation cycle will address regulatory audit observations related to revalidation, deviations and multiple release management. The Configuration and Experimentation approach cannot be achieved through traditional configurable software. The configurable Software must have visual modeling capabilities which are commonly known as No code/Low Code Development Platforms. These platforms support Visual Modelling (The user can see the making of application) The organizations must ensure that the software service provider agrees to offer configuration and experimentation as part of the V Model. If the pre-validated software or configured software follows this model, implementation times can be reduced by 70 percent. This way, gaps can be easily identified during the Configuration and Experimentation phase and as implementation time gets reduced and allows us to complete OQ in 25 percent of the total project time. No code/ Low code Platform These platforms allow business and IT to collaborate in real-time, using visual models to capture business requirements as well as quickly iterate and scale apps while ensuring nothing gets lost in translation. The platform allows users to quickly turn their ideas into building up applications and transforming their manual processes to digital within days. Low Code or No-code development platform provides drag-and-drop tools that allow business process engineering (BPE) teams to develop software quickly without coding. The platforms provide drag-and-drop components to quickly assemble and design applications at reduced timelines and efforts. They also help increase business productivity and efficiency at the work levels. Both developers and non-developers can use these tools to practice rapid application development with customized workflows and functionality. Global enterprises are looking for No Code Platforms to build actionable digital strategies for every part of their business. When prevalidated GMP software like QMS, DMS, LMS, eBMR and Batch Issuance software were built on using this No Code/ Low code Platforms then addressing the Requirement gaps or change will be faster and minimal time with less no of people involvement. Even change management becomes easy using No Code Platform. Processes can be changed every now and then, even for a small change in the traditional approach will take months’ time, using the No-code platform can happen in days’ time. The platforms offer Visual modeling of business logic and workflows, with the ability to extend with custom code Visual definition of data models Drag-and-drop implementation of modern user interfaces for multiple devices Application change and life-cycle management The way forward for pharma organizations This is the time for pharma organizations to step towards selecting pre-validated software with visual modeling capabilities (No/ Low Code Platforms) that helps business users in appealing digital experiences with human readable application models by keeping the cost constant. Way forward for IT organizations Software suppliers must focus

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March 20, 2023

TOP 3 Trends Transforming Outlook of Pharmaceutical Industry In 2023

COVID-19 spurred a sense of urgency in healthcare and pharma professionals, making the entire landscape conducive to change and digital transformation. We’re at a strange crossroads. On one hand, it feels as if the world stopped calculating the passage of time starting in March of 2020. On the other hand, in the healthcare industry, it feels as if we’ve sped ahead by two decades, with the normally slow pace of innovation breaking all kinds of records and expectations. The pharma industry has been slower to embrace technologies such as AI and digital technology however, COVID-19 pandemic has changed the equation, forcing pharma companies to become more agile and open-minded in approaching drug discovery and development. There has been a tremendous amount of growth in the pharmaceutical industry in recent years from embracing new technologies, patient design, and innovations and put a greater focus on prevention and digital health and the outlook continues to be positive for 2023. In this article, we are sharing Top 3 trends that shall transform the outlook of pharmaceutical industry in 2023. 1. Use of Artificial Intelligence Artificial intelligence in Pharmaceutical Industry has an unimaginable potential. Within the next couple of years, it will revolutionize every area of our life, including medicine. A.I. is already on our wrists, in our cars, in the searches we do or what we are offered to buy, Imagine this efficiency in healthcare! Artificial Intelligence will soon revolutionize healthcare through mining medical records, designing treatment plans, speeding up medical imaging, create more affordable drugs ad therapies, and, most importantly, reduce operational costs. A recent report forecasts the global artificial intelligence in pharma is projected to grow from $699.3 million in 2020 to $2,895.5 million in 2025 at a rate of 32.9%. The market is then expected to grow at a CAGR of 25.9% from 2025 and reach $9,142.7 million in 2030. The combination of AI, big data and IoT technologies are creating new innovations, also other eminent technologies like cloud computing, augmented reality, virtual reality and blockchain are being used extensively in the Pharmaceutical industry’s digital transformation. Over the past decade, the FDA has reviewed and authorized a growing number of devices legally marketed with ML across many different fields of medicine—and expects this trend to continue. AI can present a myriad of opportunities for the pharmaceutical industry bringing about a radical shift in the innovation paradigm of the pharma sector. It’s all about the speed and savings that Artificial Intelligence’s myriad of applications can bring in Pharma sector. 2. Digital Health: From a solution to an ecosystem The sink or swim mentality brought on by the Covid pandemic accelerated innovation in every aspect of healthcare. The year 2023 is expected to witness a steep surge in the use of electronic prescriptions with the idea of reduced paperwork and longevity in storage. Digital Prescription is one innovation that is transforming the healthcare landscape to create digital health records of patients which in turn improves patient outcomes as this reduces the chances of human error to interpreting wrong medicines. The concept of Remote Patient Monitoring gained huge popularity during the COVID-19 pandemic when people had to follow movement restrictions and social distancing norms. RPM is slowly becoming the future of delivering healthcare services to patients by providing them with an array of medical devices such as implantable, blood pressure cuffs, sensors, and many others so doctors can access real-time patient data for better treatment. Wearable technology in healthcare allows patients to play a more active role in maintaining their health. Patients, equipped with wearable technologies, can track everything from heart rate to reproductive cycles. Doctors can also use this data to craft individualized healthcare plans. Furthermore, the data mined from wearables is more systematic and accurate in recording all medical details and vitals of the patient. 3. Precision Medicine Precision medicine is a medical model that proposes the customization of healthcare, with medical decisions, treatments, practices, or products being tailored to a subgroup of patients, instead of a one‐drug‐fits‐all model. Tailoring a drug to a specific diagnosis is the first step in personalized medicine. However, a patient’s body may react poorly to the medication. Precision medicine looks to solve this issue by targeting drug development based on more in-depth knowledge about the patient. For example, the use of biomarkers to identify tumors and develop a drug specific to that exact diagnosis. The goal is to create and prescribe the drug with the highest level of effectiveness and positive outcomes for the patient, and it’s an approach that is exploding within the pharma industry. Investment in precision medicine from leading pharmaceutical companies will experience an increase in the next five years  and as per the recent report, the global precision medicine market is expected to grow at a CAGR of over 11.5% from 2021 to 2027. This demonstrates the commitment to acceleration in precision medicine research from the biggest pharmaceutical companies. The challenges facing precision medicine have to do with its manufacturing, which require smaller, more specialized facilities. Despite this challenge, precision medicine still shows an upward trend in the pharma industry.  These top trends are changing the pharmaceutical industry in ways that are transformative and likely to have both a short- and long-term impact. The level of innovation that’s taking place in the industry is likely to create tremendous value in accelerating growth of Pharma Industry towards Pharma 4.0. Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and

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March 20, 2023

Pharma 4.0: Faster Digitalization with Low Code Platforms

Digitalization: An Evident Automation Revolution, Is automation a step-up for healthcare? Talking about digitalization will surely uncover a lot of facts, insights and statistics in contemporary industries. Whenever a new technology comes, it comes as a boon to humanity, but it also brings up a lot of unforeseen outcomes, and that’s the whole pact. Similarly, digitalization has impacted many businesses in both ways and the pharma industry is the one among them, especially during the ongoing fitful pandemic. Life science companies being processed manually from ages are now transforming themselves to adopt digitalization with pharma automation. Yes, it is a big change! Besides, the Food and Drug Administration (FDA) in its 21 CFR Part 11 compliance, has made a regulation that all the paperwork processes have to be made digital with e-documents and e-signatures. The motto of the regulation is to encourage medical management systems to adopt automation as a pillar to run the entire supply chain smoothly. Challenges In Healthcare Supply Chain During COVID-19: What are the reasons behind the dysfunctional processes? With an unpredictable virus-led pandemic on the head, it has been a terrific scenario all around the globe. And healthcare was not an exception, rather it faced or is facing so many challenges in staying stable with the disrupted supply chain system. Lacking automation in pharma, here are some prevalent issues, mentioned below, became hurdles for life science industries: Shortage of resources; Raw materials, labours, time Coming up with assorted feasible solutions to deal with the virus, as per the demand Slow travel time of products (drugs, medicines. etc.) that made the delivery halted and reach the market slower Staying updated and keeping people updated with the health rules and regulations during the new normal Delivering quality assistance with a recovery assurance; Step by step testing, treatment, etc. Demand of vaccines all over the world has also been a pressure Lacking full-fledged technological involvement in the treatment with minimal automation in pharmaceutical industries Disintegration of the whole streamline operation When we see a lot of challenges in the whole healthcare supply chain, we also have to keep a tab on the deadly repercussions of the pandemic. With a global death of 3.94 Million, it is high time to inculcate automation into the life science management systems. Welcome Digitalization with Low Code Platforms: Why digitalization a tough job for pharma companies? Where a lot of pharma industries are getting influenced with this idea of digitalization, a few things still are becoming barriers; tough code-run and program-based features. “But have you heard about Low Code Platforms?” Yes, that’s what we will be talking about, and that sort of digitalization is the one that will definitely not scare out any pharma business. Low Code Platform is a more resolved and stress-free version of the app development process. With this, many businesses handle their end-to-end business tasks, starting from customer support to lead generation and many more. Many pharma automation companies are now adopting Low Code Platforms to accelerate their business as well stay strong in the market, pleasing their target customers. What do you get with a Low Code Platform to showcase your business in digital mode? Visual Modelling tools (or apps) with in-built features, where you do not have to juggle with confusing codes and programs. You can easily put your information and it will be readable to everyone starting from laypersons to professionals. Out-of-the-box functionalities, where you don’t need to start making an app from scratch, rather you can just pick a particular section or module to build. Easy drag and drop features make things operate hassle-free for a pharmaceutical automation industry An app with pre-installed modules, plug-ins that functions faster Accessible to every device A fully functional and secured digital platform Scalable features allowing further growth possibilities in business Transparent application lifecycle management that takes the consent of the user before making any change in the app and also inform the user about everything going on the platform Pharma 4.0: A quick peek: Is digitalization a benefitting deal for pharma sectors? Of course, digitalization when implemented with all the smart strategies, is the ultimate success code to boost any business. The rapid digitalization in several industries is showing a huge probability of completely rooting out traditional ways of manual processing. And with this, industry 4.0 came into the picture, which is a perfect combination of digital technology and innovation, and it is ready to channelize industrial revolution all around the globe. So, with industry 4.0 in the pharmaceutical industry we see a good hope of growth in life science industries also, benefiting both the supplier and the consumer. Pharma 4.0 is nothing but a strategic series to be implemented in the pharmaceutical manufacturing process, where every phase of the chain will be digitalized and keenly monitored, starting from the manufacturing operation to the end delivery. This is an amazing time to accept a profiting transformation. Isn’t it? This will not only make your pharma business smoother but also will help you serve your consumers efficiently. This is certainly a good deal! Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom (UK)United States (US)United States (US) Minor Outlying IslandsUnited States (US) Virgin IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabweWhere you heard about us?– Select –Google SearchLinkedInReferralWord of MouthLinkedIn AdsMediumRequirementGet in touch

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March 18, 2023

Why growing Pharma Companies should automate their Quality Process

Automation Impacting Quality Process Quality Process Automation is not only the requirement of well-established pharma companies but also there is a huge demand and need for automation in Pharma Startups. Digital Transformation for growing companies is the need of time as this will help the companies to battle the data integrity issues and standardize the quality process with one-time investment cost. Few points which we can elaborate to focus on the need for growing pharma companies to automate their quality process Easy Configuration A flexible EQMS system should provide an easy configuration which doesn’t require complex coding. Primarily Quality team in pharma manufacturing companies should focus on their core functional activities rather than thinking about coding and building a QMS application or implement new electronic processes, as being a Pharma startup they might not have a dedicated development team. Ease of configuration is desirable for an EQMS with drag and drop functionality. Drag and drop functionality will help to easily build the applications without the need to know the coding. Simple configuration is desirable for pharmaceutical companies because it reduces the need for dependency on application experts, and it can simplify requirements. Extensive system configurations which incorporate programming can complicate things makes the validation process complex. Document Management Document Control is needed in every phase of scale-up and growth. It is a prime requirement of the companies QMS during all stages. Avoid the creation of multiple copies of the same document or spreadsheet and prioritize document management with a standard template, numbering format and simple web-based editor with secure login access to establish systems and create, update documents with collaboration through each stage of the document workflow. Pharma growing companies need a QMS/EQMS which excels at document control to provide a smooth and satisfying user experience and stabilize documentation from the beginning. The system should be able to scale up from the earliest requirements to FDA inspections, and offer features for FDA-compliant e-signatures, audit trails, with integration across other QMS modules. Training Management Pharma growing companies need role-specific training at every stage of business growth to establish compliance and achieve standards. Quality Management System needs to adhere to regulatory requirements that suppliers “establish and maintain documented procedures” for identifying training and train all staff who can impact quality. Quality Management (EQMS) software should also provide reliable documentation of training performance to fulfill standards. In every stage, companies can get benefit from graphical representation and analytical trends with metrics across a growing organization. Market Complaints Management Pharmaceutical growing companies should be prepared for the future and track the marker complaints from the beginning. If the process is standardized it will help the companies even if they scale up in the future which is bound to happen in the Pharmaceutical Industry. Audit Management As the products are bound to reach the review and approval phases with the FDA, pharma growing companies should be prepared to comply with audit requests. Flexible features like annual audit calendar, automated audit report creation, audit evidence capture help the companies to reduce the time and effort involved for preparation of audit a prime focus of area during a regulatory audit. Integrated audit management system with other QMS modules can provide the necessary systems to reduce regulatory risk. Selecting an EQMS with these capabilities can ensure that the system will scale to market. Understanding the requirements at a granular level, and translate those requirements into applications in a visual way eases the process and decreases the time of implementation. Please do drop us an email at info@amplelogic.com or visit www.amplelogic.com for any compliant solutions for your quality operations. Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom (UK)United States (US)United States (US) Minor Outlying IslandsUnited States (US) Virgin IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabweWhere you heard about us?– Select –Google SearchLinkedInReferralWord of MouthLinkedIn AdsMediumRequirementGet in touch

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March 18, 2023

AmpleLogic: Proffering Benefits and Maximum Quality at Minimal Cost

As digitalization has become inevitable, to fulfill their unique automaton requirements, businesses are either developing their software the traditional way or opt for ready-to-use software, which is touted to be cheap, but succumbs hefty monies for modification. On the other hand, besides consuming a dismal amount of money, the trample of traditional software development method treads down numerous potentially genius ideas, due to the long chain of command (that involves multiple stakeholders akin to project manager and architect) between the business analyst and developers during the 2-6 months deployment time. Considering the amount of time and cost it would require to change a single idea, it is safe to say that the codes are set in stone once it leaves the hand of a business analyst. The AmpleLogic team can deliver custom solutions at 8 times faster than Traditional IT service delivery Companies. “Easily integrated with bio-metric devices to address the password sharing problems, Ample Logic allows users to login into multiple application son premises with one set of credentials.” This is where AmpleLogic enters the picture with its Low Code Application Development Platform, which is a powerful responsive application development platform that enables configuration of complex business applications very efficiently with little help from technical teams. Cutting down the deployment time to mere three days, this platform allows business analysts to easily manage the change as the idea evolves at a very less cost, not to mention the luxury of observing how the application looks while analysts are creating it. Moreover, the platform is capable of addressing 80 percent of an organization’s needs without writing a single line of code. AmpleLogic has created 25 applications and added 12 components to accommodate the validations and business logic. Maximum Quality at Minimal Cost “To provide the best IT Solutions to our customers, being a growing company we would like to standardize our delivery automation. Good amount of time and money was invested to build a world-class No-Code development platform that helps in delivering the solutions eight times faster than traditional models with high quality,” expounds Venkanna Chowdary Manne, Managing Director, AmpleLogic. Noting that it fits perfectly with packaged solutions and runs on existing infrastructure, it doesn’t incur any customization cost. Moreover, AmpleLogic has priced its solutions competitively to ensure ROI within six months. With a sheer focus on Pharma, IT Infrastructure & Excel Automation, AmpleLogic team has built multiple applications on the platform. Excel has become an integral part of professional life, but there are still many unanswered questions when it is shared among a big group with multiple owners. Being a Microsoft Partner company, AmpleLogic endows its clients with MS Excel that has an automated tool features such as a centralized database that can be accessed from Excel, Secure Data Access with Active Directory, in-built workflow, role-based access, and automated emails, audit trials – all this without the help of any additional software. The company’s vast experience gained in specialized in MES (Manufacturing execution system) for Semiconductor Assembly and Test, made AmpleLogic confident enough to design, develop and integrate ERP Systems to crucial areas of a building component. AmpleLogic has designed its MES system with Resource Planning specifically to integrate crucial areas of Raw material to Production, to equipment booking management and inventory control. The solution covers software, installation, ongoing training, and professional support, thus helping streamline client’s business processes to maximize productivity and profitability by addressing the complex issues. “Our unique excel automation streamlines the multiple Excel movements and versions by keeping User Experience intact,” expounds Venkanna. Demystifying the IT Infrastructure Puzzle As computer networks are getting more and more complex, the use of native tools or power shell requires dedicated resources with a deeper knowledge in Active Directory (AD) Management and related technologies. Keeping this in mind, AmpleLogic has developed a comprehensive AD suite with twenty features in user management, seven in Group Policy, six in OU, eleven in distribution & security groups and seven features that can make changes to many computer objects simultaneously, thus minimizing the time and complexity in computer management. Easily integrated with biometric devices to address the password sharing problems, AmpleLogic allows users to login into multiple applications on premises with one set of credentials. SSO with biometric integrations enforces password policies. The company’s ready-to-use IT Infrastructure Management solutions simplify IT management, improve productivity and allow administrators to proficiently manage the applications, systems, endpoints, and devices. With real-time alerts and notifications, the company with its IT infrastructure audit service helps administrators to crush the challenge of collecting the configuration changes & object level changes in tracking who, what, when & where the changes were made. Furthermore, the self-service option at windows login reduces help-desk workload and ensures password security. This ISO 9001-2000 certified company’s IT Infrastructure Solutions deliver value and gets control on the IT Infrastructure. Also, AmpleLogic’s Print Tracking software helps the organizations to track print activity in the entire organization. Facilitating Good Manufacturing Practices AmpleLogic Pharma QMS Software and CGMP Quality Management Solution brings forth exceptional transparency across Quality Systems and resolve quality issues down their roots. The company provides adaptable graphical interface builders so that their solutions ensure complete competency into the client’s SOPs while being cost effective. AmpleLogic quality solutions enables clients to achieve good manufacturing practices (GMPs) at production facilities with Batch Record Issuance Management System (BIMS), a 21 CFR Part 11 Compliant solution with a blend of Document Management and an Issuance Management. Facilitating the FDA Current Good Manufacturing Practice (CGMP) regulated companies to demonstrate the process transparency of every production step, AmpleLogic enables easy integration with quality systems like CAPA, Incident and Deviations to enrich the process performance and traceability across the manufacturing process. AmpleLogic Market Complaints Record, Management and Tracking Software automate complaints handling through robust root cause analysis tools, 24×7 global web accessibility that helps intake the complaints & respond immediately, assessments and closure with any associated CAPA. This enables organizations to acquire and retain customers through positive customer experience. “Our client-focused IT solutions mark the right balance of Quality, Reliability, Delivery and Pricing,” remarks

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March 18, 2023

Is the Learning Management System a new-age demand for digitalization today?

Traditional learning being powered up with LMS: If we talk about various achievements or success these days, we must have heard a lot about e-learning or e-certifications, etc. An, LMS Software is the vital platform these days helping resources get more resourceful with multiple options to get themselves upskilled. LMS, known as Learning Management Systems, is a one-stop-shop to several courses and study materials, which can be accessed anytime without any hassle. The main objective of an LMS in industries these days is to contribute to upskilling internal employees, which in turn will help the companies to grow in their missions. With the Learning Management System for Pharmaceutical Companies, it has been way simpler to bring all the training agendas and learning materials at one common point. Then it assigns training to respective individuals as per their domain and expertise. In this way, the company gets a chance to proffer adequate training to the employees, as well as every employee get all the on-job training updates without any miss. When many industries may state that these all things can be managed efficiently on papers without involving any sort of software, but with LMS Software System in action, the whole manual exhaustive process becomes automatic and more resolved. Why LMS in Lifesciences? Though every industry these days must integrate themselves to the whole digitalization activity encouraging automation, the Learning Management System is one of the most required digital movements to be implemented in every pharma and lifesciences industries. There has been an emerging need for pharma and lifesciences industries to stay updated with every trending change in several compliances. To satisfy that purpose, AmpleLogic LMS is proffering employees preferable training according to a certain hierarchy. Separating technical, non-technical, sales, marketing, HR, etc., the LMS will efficiently decide which training to be given to which employee as per the Standard Operating Procedures (SOP) and policies. Undeniable benefits can be availed with LMS Software: Gone were the days when we used to wait for a specific time to get the desired training to upgrade our skills. With digitalization in power, we can access our interested learning sections whenever and wherever we need, that’s why we term it as e-learning. Isn’t it more exciting? That’s the comfort we have reached through digitalization and as a part of it, the training management system in pharma industries these days has strengthened the whole learning technique with certain amazing automation impacts. Here are some engaging benefits of LMS, which will insist you to inculcate digitalization in your business: LMS creates a modifiable one-place hub for all the learning materials where you can now create, add, manage, update, and share the study material you want a learner to have. AmpleLogic’s LMS Software for Pharma when flexibly integrated with DMS gives access to SOP documents and makes the learning process more customized recommending accurate training to each employee. There is a well-organized library having all the study materials gathered altogether and accessible to every learner. Pre-explained learning content like inductions training for the new joinees, product training, etc., can be saved in the LMS Software, which will be available to employees as per their stages of learning and relevant experiences. Using the platform, the training coordinator can create specialized training for new employees as well as transferred employees. Encouraging on-job training (OJT), this efficient platform offers several departments to insert pre-described modules, helpful for easy understanding. Offline sessions, practical demonstrations, self-reading, etc. are the sort of learning materials one can easily avail through LMS. According to the availability and feasibility one can easily reschedule sessions. Along with the training, employees will be given the certificates for completing the sessions as per their specific roles. From the DMS, LMS will get a thorough data of the employee and the course coordinator will arrange recommended training to be given to the employee. Learning Management in corporate sectors are specially designed to fit into employees’ time schedule as they will be continuing the training along with their job. So, the platform allows needed modifications and relaxations. Unlimited access to all the content stored at one place makes the platform a favourite for most of the pharma and lifesciences industries these days. When you have all the in-house training to feed your resources, you make your employees happy, content, and productive at the same time. There are uncountable benefits an industry can have using LMS Software in their businesses with utmost automation. This digital trend in digitalization in pharma is making the learning process easy and fun. This training software is also helping employees to get more active at work and is a good deal for a business. Ever thought of incorporating LMS into your pharmaceutical business? We will help you out with all your queries. Book a quick demonstration on LMS by AmpleLogic and get it integrated with your trending businesses. Contact us for a demo on AmpleLogic Pharmaceutical Learning Management System, write to us on info@amplelogic.com Schedule a Free Consultation Request a Demo First NameLast NameCompany NameEmailPhone NumberDesignationCountrySelect CountryAfghanistanAland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelauBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Saint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the Congo (Kinshasa)DenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyIvory CoastJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKosovoKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacao S.A.R., ChinaMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalestinian TerritoryPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of the Congo (Brazzaville)ReunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint Martin (Dutch part)Saint Martin (French part)Saint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia/Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited Kingdom (UK)United States (US)United States (US) Minor Outlying IslandsUnited States (US) Virgin IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabweWhere you heard about us?– Select –Google SearchLinkedInReferralWord of MouthLinkedIn AdsMediumRequirementGet in touch

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