Video 2: Data Integrity Principles — ALCOA, Data Lifecycle and EU GMP Developments

# Data Integrity Principles — ALCOA, Data Lifecycle and EU GMP Developments | Video 2 📘 **DATA INTEGRITY IN PHARMACEUTICALS — VIDEO 2** Welcome to **Video 2** of the Pharma Best Practices educational series on *Data Integrity in Pharmaceuticals*. This video examines the fundamental principles of data integrity, their application throughout the data lifecycle, and recent regulatory developments in the European Union. The discussion is based on official guidance and regulatory documents published by the **US FDA, UK MHRA, WHO and European regulatory authorities**. 🔍 **WHAT DOES THIS VIDEO COVER?** ✅ **Understanding Data Integrity Principles** An explanation of the attributes represented by ALCOA: • Attributable • Legible • Contemporaneous • Original • Accurate The video also explains the additional ALCOA+ attributes: • Complete • Consistent • Enduring • Available ✅ **Traceability and ALCOA++** An explanation of traceability and its relationship to reliable pharmaceutical records, including the ability to follow the history of data and recorded changes. ✅ **Data Integrity Throughout the Lifecycle** How data integrity principles apply to the generation, processing, review, storage, retention and retrieval of pharmaceutical information. ✅ **FDA, MHRA, WHO and EU GMP Perspectives** How the four regulatory frameworks address the reliability of pharmaceutical data, data governance and appropriate recordkeeping controls. ✅ **Proposed EU GMP Chapter 4 Revision — July 2025** An overview of the proposed provisions concerning: • Data governance and lifecycle management • Data integrity risk management • ALCOA++ principles under draft Section 4.63 • Electronic, paper-based and hybrid records ✅ **Proposed EU GMP Annex 11 Revision — July 2025** An introduction to proposed developments concerning computerized-system controls, access management, audit trails and data integrity. 📌 **IMPORTANT REGULATORY CLARIFICATION** The proposed revisions to EU GMP Chapter 4 and Annex 11 were published for consultation in July 2025. **As of November 2026, these revisions have not been adopted as final EU GMP guidelines.** The January 2011 versions remain the currently published texts. This video clearly distinguishes existing regulatory requirements from proposed revisions. 🎯 **WHO SHOULD WATCH?** 🔹 Quality Assurance and Quality Control professionals 🔹 Pharmaceutical Manufacturing personnel 🔹 Regulatory Affairs and Compliance professionals 🔹 Computer System Validation and IT professionals 🔹 Laboratory professionals 🔹 Students and young pharmaceutical professionals The video may also be used for **professional education and training**. 📚 **OFFICIAL REGULATORY REFERENCES** 🇺🇸 **US FDA — Data Integrity and Compliance With Drug CGMP (2018)** https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers 🇬🇧 **UK MHRA — GxP Data Integrity Guidance (2018)** https://www.gov.uk/government/publications/guidance-on-gxp-data-integrity 🌍 **WHO — Guideline on Data Integrity (2021)** https://www.who.int/publications/m/item/annex-4-trs-1033 🇪🇺 **EU GMP — EudraLex Volume 4** https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en 🇪🇺 **European Commission — Proposed Revisions to Chapter 4 and Annex 11 (2025)** https://health.ec.europa.eu/consultations/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-4-annex_en ▶️ **NEXT VIDEO — VIDEO 3** **Data Governance — Management Responsibility, Quality Culture and Personnel** 🌐 **ABOUT PHARMA BEST PRACTICES** Pharma Best Practices is a **not-for-profit educational initiative** dedicated to sharing pharmaceutical regulatory knowledge, scientific understanding and good practices. 🔔 **Subscribe** to follow our Data Integrity in Pharmaceuticals series. 📢 **Please share this video** with colleagues and young pharmaceutical professionals who may benefit from these educational resources. **Pharma Best Practices — Sharing Knowledge, Promoting Better Practices.** #DataIntegrity #ALCOA #ALCOAPlus #ALCOAPlusPlus #EUGMP #USFDA #MHRA #WHO #GMP #PharmaBestPractices #PharmaTraining