Articles tagged with “eu-gmp-annex-11”

GxP Audit Trails for AI: 21 CFR Part 11 & Annex 11 Rules

Explore GxP audit trail requirements for AI systems. Review 21 CFR Part 11, Annex 11, and ALCOA+ rules for logging training data, prompts, and model outputs.

40 min read

2/4/2026

gxp compliance audit trails data integrity 21 cfr part 11 eu gmp annex 11 artificial intelligence alcoa+computer system validation ai governance

21 CFR Part 11 for AI Systems: An FDA Compliance Guide

Navigate FDA 21 CFR Part 11 for AI systems. This article details compliance strategies for validation, audit trails, and data integrity in regulated GxP setting

40 min read

12/30/2025

21 cfr part 11 artificial intelligence fda compliance gxp data integrity system validation ai in pharma eu gmp annex 11 machine learning