Tag: Computerized Systems

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EU GMP Annex 11 versus FDA 21 CFR Part 11 comparison for computerized systems and electronic records

Annex 11 vs 21 CFR Part 11: Comparison and GMP Requirements

Comparison of Annex 11 and 21 CFR Part 11, with practical takeaways on validation, governance, risk management, audit trails, electronic...
Good Documentation Practice (GDocP) in GMP, highlighting the role of structured, controlled documentation in ensuring data integrity, regulatory compliance, and trustworthy pharmaceutical records.

Good Documentation Practice (GDocP) in Pharma

A practical guide to Good Documentation Practice (GDocP) in pharma, covering ALCOA++, data integrity, inspections, electronic records, and compliance controls....
EU GMP Guidelines draft updates: Chapter 4, Annex 11, and new Annex 22 - What is about to change?

2025 EU GMP Draft Updates: Chapter 4, Annex 11, and Annex 22 – What’s Changing?

The 2025 EU GMP draft revisions to Chapter 4, Annex 11, and Annex 22 bring major changes to documentation, computerized...

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