ISPE GAMP AI Guide: Validation Framework for GxP Systems
Review the ISPE GAMP AI Guide for validating machine learning in GxP. Learn the risk-based framework for data integrity and regulatory compliance.
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Articles tagged with “computer-software-assurance”
CSA vs CSV: Validating AI Systems Under FDA Guidance
Compare FDA's Computer Software Assurance (CSA) vs CSV for AI systems. Learn risk-based validation strategies for machine learning in life sciences.
CSV to CSA: Understanding FDA's New Validation Guidance
Analyze the transition from CSV to FDA's Computer Software Assurance (CSA). This guide details risk-based validation strategies and compliance impacts.
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
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.
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
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
GAMP 5 Second Edition: A Guide to Key Changes & Updates
Learn the key updates in ISPE GAMP 5 Second Edition. Updated for 2026 with FDA's finalized CSA guidance, ISPE GAMP AI Guide, and EU Annex 11/22 revisions
Understanding 21 CFR Part 11: Electronic Records & Signatures
Learn about 21 CFR Part 11, the FDA regulation for electronic records and signatures. Updated for 2026 with the latest FDA guidance on electronic systems, Computer Software Assurance (CSA), and GAMP 5 Second Edition.