Articles tagged with “computer-software-assurance”

AI/ML Validation in GxP: A Guide to GAMP 5 Appendix D11

Learn to validate AI/ML systems in GxP manufacturing using the GAMP 5 Appendix D11 framework. Explore key considerations for data integrity, risk, and model dri

30 min read

1/5/2026

gamp 5 ai validation gxp compliance pharmaceutical manufacturing computer software assurance 21 cfr part 11 data integrity machine learning validation

FDA CSA Guidance: A Pharma & Biotech Compliance Guide

Understand the FDA's final Computer Software Assurance (CSA) guidance, a risk-based shift from CSV for pharma & biotech. Learn key principles for compliance.

30 min read

12/27/2025

computer software assurance fda guidance software validation gxp compliance risk-based validation pharma manufacturing 21 cfr part 11

GAMP 5 & CSA: A Practical Integration Guide for Pharma

Learn how to integrate GAMP 5 (2nd Ed.) and Computer Software Assurance (CSA). This guide details the shift from CSV to a modern, risk-based validation strategy

40 min read

12/26/2025

gamp 5 computer software assurance csa risk-based validation pharma it gxp compliance fda guidance

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