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:

  1. Centralized Storage: eDMS provides a centralized repository for all documents and data, ensuring easy access, retrieval, and management of critical information.
  2. Version Control: The system records document versions, revisions, and updates, minimizing the risk of using outdated or incorrect information.
  3. Audit Trail: eDMS creates an electronic audit trail that captures user actions, edits, and document history, offering transparency and accountability.
  4. Role-based Access: Access controls and permissions are enforced, limiting document access to authorized personnel enhancing security and confidentiality.
  5. Electronic Signatures: Digital signatures add an extra layer of authenticity to documents, making them legally binding and tamper-proof.
  6. Workflow Automation: Automated approval workflows streamline document review and approval processes, reducing human errors and accelerating document lifecycle.
  7. Data Integrity Checks: eDMS can include built-in data integrity checks to ensure accurate data entry and prevent inconsistencies.
  8. Validation and Compliance: eDMS platforms can be validated to comply with industry regulations like 21 CFR Part 11, EU Annex 11, and GxP guidelines.
  9. Reduced Paper Usage: By transitioning from paper-based to electronic processes, errors due to manual data entry are minimized.
  10. Real-time Collaboration: Teams can collaborate on documents simultaneously, promoting real-time feedback and updates while maintaining data integrity.
  11. Search and Retrieval: Advanced search capabilities in eDMS enable quick retrieval of documents, reducing time spent on data searches.
  12. Backup and Disaster Recovery: eDMS systems often include data backup and recovery mechanisms, safeguarding documents against loss or corruption.
  13. Regular Audits: The system supports regular audits and inspections, ensuring data integrity and regulatory standards compliance.
  14. Data Validation: eDMS can include validation checks to ensure data accuracy, completeness, and adherence to predefined formats.
  15. Training Records: eDMS can manage training records, ensuring that personnel accessing documents are adequately trained and qualified.
  16. 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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Root Cause Analysis with example for “5” Why technique

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DMS

Why is embracing the Document Management System still intimidating?

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When crucial data is stored in the cloud then there comes a major terror of data being vulnerable and being attacked by malicious cyber frauds. Hence, it is required to maintain utmost cybersecurity ensuring the documentation is safe in the cloud kept away from cyber thefts. Doubt on successful implementation: There are so many growing features of Electronic Document Management and Tracking Software for Lifesciences industries, but we need to explore all those specifications accurately. Adding on a digital trend to a business could sound fun, but the real game starts when you implement the software effectively. This can be done with active seminars, group discussions, and taking feedback from employees (who are using it) on document management solution. Fear of smooth integration: The DMS must come up with appropriate integration of all relevant departments, then only we can assure its potential usage. 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Benefits of Training Management System

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

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