Articles tagged with “ai-governance”

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

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