Articles tagged with “pharmaceutical-validation”

Validating Generative AI in GxP: A 21 CFR Part 11 Framework

Updated 2026 framework for validating generative AI in GxP systems. Covers 21 CFR Part 11, EU Annex 22, ISPE GAMP AI Guide, FDA CSA guidance, and FDA-EMA joint AI principles

40 min read

10/28/2025

generative ai 21 cfr part 11 gxp computer software assurance data integrity pharmaceutical validation alcoa+life sciences fda compliance eu annex 11 ai