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GAMP 5® Second Edition Overview, Themes & Objectives

‐ May 9, 2023 4:45pm

GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) maintains the principles and framework of the first edition and updates their application to reflect the realities of the modern world, including the increased importance of service providers, evolving approaches to software development, and ever-increasing use of software tools and automation. The presentation covers the drivers and objectives for change as well as giving an overview of new and updated material.


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