GAMP 5 in Pharma – What It Really Is, Why FDA Loves It & How to Implement It Practically My Quick Take: GAMP 5 is not a regulation. It’s a guideline – a guidebook written by ISPE to help us validate computerized systems in a simple, risk-based way. If 21 CFR Part 11 tells you … Read more
21 CFR Part 11 Explained: Complete Guide to FDA Electronic Records & Signatures (2026) By PharmaShare CSV Team | Data Integrity | August 2026 Quick Summary: 21 CFR Part 11 is FDA rule for accepting electronic records & signatures as equivalent to paper. Applies if you use computers in GMP/GLP/GCP. Requires Audit Trail, Electronic Signature … Read more
