Articles tagged with “risk-based-validation”

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.

35 min read

2/7/2026

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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.

30 min read

2/6/2026

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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

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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

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GAMP 4 vs GAMP 5: Key Differences & Migration Guide

Learn the key differences between GAMP 4 and GAMP 5. Updated for 2026 with FDA's finalized CSA guidance, ISPE GAMP AI Guide, and EU GMP Annex 11/22 drafts. Clear migration path for pharma IT.

40 min read

10/15/2025

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