EU Annex 11 Draft 2025 Update Explained | What’s New in Pharma Compliance & Computerized Systems

EU Annex 11 Draft 2025 Update Explained | What’s New in Pharma Compliance & Computerized Systems

The European Medicines Agency (EMA) has released a draft update of EU Annex 11 (2025) — the most important guideline for computerized systems in pharma.

In this video, we break down: https://youtu.be/zuoAz5nDgVk
✅ What Annex 11 is and why it matters
✅ The new draft updates for 2025
✅ Key differences between the 2011 version vs 2025 draft
✅ Implications for QA, QC, IT, RA, Validation, and Regulatory Affairs teams
✅ What this means for pharma companies worldwide

0:00 – Hook & Intro – Why EU Annex 11 draft 2025 matters
0:25 – Background – Quick recap of EU Annex 11 (2011 version)
0:55 – Key Updates Overview – Main changes introduced in the 2025 draft
1:35 – Focus on Section 4 – Governance, responsibilities, and data integrity
2:05 – Other Major Updates – AI, cloud computing, cybersecurity, digitalization
2:45 – Impact on Pharma Companies – Compliance and audit readiness
3:15 – Final Thoughts – Preparing for adoption & staying compliant
3:35 – Call to Action – Subscribe to Pharmalytics for compliance insights
If you’re preparing for pharma license exams, working in Quality Assurance, or managing compliance in IT systems — this video will help you stay ahead.

👉 Subscribe to @Pharmalytics for more updates on pharma compliance, regulatory affairs, and industry training.

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