Articles tagged with “machine-learning-validation”

Enterprise AI Governance in Pharma: GxP & Compliance

Explore AI governance frameworks for pharmaceutical companies. Learn to align AI with GxP, FDA regulations, and data integrity standards for safe adoption.

40 min read

2/8/2026

ai governance pharmaceutical industry gxp compliance fda regulations data integrity machine learning validation risk management gamp 5

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