Validating AI in GxP: GAMP 5 & Risk-Based Guide
Learn AI/ML validation in GxP using GAMP 5 2nd Ed. and FDA CSA. Explains risk-based lifecycles, data integrity, and compliance for adaptive models.
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Articles tagged with “eu-annex-11”
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
Automating Audit Trail Compliance for 21 CFR Part 11 & Annex 11
An explanation of regulatory requirements for audit trails under 21 CFR Part 11 and EU Annex 11, covering automation strategies, data integrity measures, and the latest 2025-2026 regulatory developments including the Annex 11 draft revision and FDA CSA guidance.
Understanding Pharma Regulatory Compliance Software Solutions
Learn about regulatory compliance software in pharmaceuticals, covering GMP, GLP, GCP, FDA 21 CFR Part 11, and EU Annex 11 standards for data integrity.
GAMP 5: Computerized System Validation in Pharma
What is GAMP 5? A practical guide to the ISPE framework for computerized system validation: the software categories, the risk-based lifecycle, and how it maps to FDA CSA, 21 CFR Part 11, and EU Annex 11.