Articles tagged with “machine-learning-validation”

AI/ML Validation in GxP: A Guide to GAMP 5 Appendix D11

Learn to validate AI/ML systems in GxP manufacturing using the GAMP 5 Appendix D11 framework. Explore key considerations for data integrity, risk, and model dri

30 min read

1/5/2026

gamp 5 ai validation gxp compliance pharmaceutical manufacturing computer software assurance 21 cfr part 11 data integrity machine learning validation