Cybersecurity
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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windlas (1)
News

Windlas Goes Live with AmpleLogic Electronic Document Management System

Windlas Goes Live with AmpleLogic EDMS System AmpleLogic is delighted to announce the successful implementation of the Electronic Document Management (EDMS) System at Windlas. We would like to take the opportunity to thank everyone involved in this implementation for their support, enthusiasm, and hard work during the course of this project. Our GMP Software Solutions is purpose-built for the life sciences sector, and eases the burden of managing quality processes, as well as solving non-quality related issues within your company and all solutions are compliant with FDA, WHO, EU Annex 11, cGMP, MHRA, ISO, and other regulations and standards that apply to their drug products. To learn more about the electronic document management software (EDMS) offered by AmpleLogic, please feel free to contact us Explore Our DMS Software About Windlas Windlas Biotech is renowned for its unwavering commitment to providing top-notch pharmaceutical development services, large-scale manufacturing services, and authentic yet affordable products to customers and consumers worldwide. With a firm belief in the power of innovation and quality, the company has become a trusted name in the pharmaceutical sector. At the heart of Windlas Biotech’s success are its dedicated employees. With a workforce of 954 talented individuals, the company operates from four state-of-the-art manufacturing facilities nestled in the beautiful city of Dehradun, Uttarakhand, India. These facilities serve as the backbone of the company’s operations, ensuring the production of high-quality pharmaceutical products. But it doesn’t stop there. Windlas Biotech has also built an extensive salesforce and distribution network that spans across 14 states. This strategic approach allows the company to market its own manufactured nutraceutical, pharmaceutical, and ayurvedic products directly to semi-urban and rural communities. By cutting out middlemen and focusing on direct outreach, Windlas Biotech aims to make its authentic products accessible to those who need them most, at affordable prices. To further strengthen its commitment to transparency and authenticity, Windlas Biotech operates under the registered name of Windlas Biotech Limited (formerly known as Windlas Biotech Private Limited). This name change reflects the company’s growth and transformation over the years while retaining its core values and dedication to providing quality healthcare solutions.

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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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dc1143be
aPaaS

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
Others

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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DMS

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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DMS

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. 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GAMP

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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GAMP

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. 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