Articles tagged with “risk-based-approach”

GAMP 5 Categories Explained: Software, Risk & Examples

Learn the GAMP 5 software categories for computerized system validation. This guide explains each category with examples and its role in a risk-based approach.

25 min read

10/16/2025

gamp 5 computer system validation gxp risk-based approach ispe software validation pharmaceutical compliance

Understanding GAMP 5 Guidelines for System Validation

An overview of GAMP 5 guidelines for validating computerized systems. Explains the risk-based approach, system lifecycle, and updates for AI and cloud tech.

20 min read

9/12/2025

gamp 5 csv pharmaceutical manufacturing ispe risk-based approach regulatory compliance system lifecycle artificial intelligence

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