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.

25 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

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