Articles tagged with “eu-annex-11”

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

Explore a risk-based framework for validating generative AI in GxP systems. Learn how to meet 21 CFR Part 11 rules, ensure data integrity, and apply CSA princip

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

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 and data integrity measures.

50 min read

8/4/2025

21 cfr part 11 eu annex 11 audit trails data integrity gxp compliance pharmaceutical regulation system validation e-signatures

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.

20 min read

6/20/2025

audit-trails data-integrity electronic-records eu-annex-11 fda-21-cfr-part-11 gmp pharmaceuticals qms-software quality-management regulatory-compliance

GAMP 5: Computerized System Validation in Pharma

This guide explains GAMP 5, its principles, and lifecycle for computerized system validation in pharma, covering regulatory compliance and real-world applications.

25 min read

5/31/2025

gamp 5 computer system validation pharmaceuticals regulatory compliance fda 21 cfr part 11 eu annex 11 ispe automated manufacturing data integrity risk-based approach