Articles tagged with “automated-manufacturing”

GAMP 5: Computerized System Validation in Pharma

This guide explains GAMP 5, its principles, and lifecycle for computerized system validation in pharma, covering regulatory compliance and real-world applications. Updated for 2025-2026 with FDA CSA guidance, EU Annex 11 revision, and ISPE AI Guide.

30 min read

5/31/2025

gamp 5 computer system validation pharmaceuticals regulatory compliance fda 21 cfr part 11 eu annex 11 ispe automated manufacturing data integrity risk-based approach