Articles tagged with “csa”

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.

40 min read

2/8/2026

ispe gamp ai validation gxp compliance machine learning computer software assurance data integrity regulatory affairs pharma ai risk management csa

GAMP 5 & CSA: A Practical Integration Guide for Pharma

Learn how to integrate GAMP 5 (2nd Ed.) and FDA's final Computer Software Assurance (CSA) guidance (Sept 2025, updated Feb 2026). Shift from CSV to risk-based validation.

40 min read

12/26/2025

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