Articles tagged with “risk-based-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

GAMP 4 vs GAMP 5: Key Differences & Migration Guide

Learn the key differences between GAMP 4 and GAMP 5. This guide for pharma IT covers the shift to risk-based validation and provides a clear migration path.

35 min read

10/15/2025

gamp 5 gamp 4 vs gamp 5 risk-based validation pharma compliance ispe gxp guidelines data integrity