eQMS
eQMS

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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AI
eQMS

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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eQMS

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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eQMS

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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eQMS
eQMS

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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eQMS

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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eQMS

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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