| 43 checks across GAMP 5, 21 CFR Part 11, EU GMP Annex 11 and PIC/S data integrity — plus an 8-point readiness check for the 2025 draft Annex 11 and the new Annex 22 on AI.
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| Most GxP computerised systems pass their own validation testing. What trips teams up in an inspection is the implementation: interfaces left outside validation scope, audit trails that never captured the previous value, access reviews that were never scheduled, a restore that was never tested.
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| GAMP 5 · 21 CFR PART 11 · EU ANNEX 11 · ICH Q9(R1) · PIC/S PI 041-1 |
