Articles tagged with “computer-software-assurance”

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

GAMP 5 Second Edition: A Guide to Key Changes & Updates

Learn the key updates in ISPE GAMP 5 Second Edition. Our guide covers the new focus on critical thinking, agile validation, cloud services, and CSA for GxP syst

25 min read

10/10/2025

gamp 5 second edition computer systems validation csv gxp compliance ispe agile validation computer software assurance data integrity