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Guidance

In: Computers and Technology

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GAMP 4 to GAMP 5 Summary
Introduction
This document provides summary information on the GAMP 5 Guide and provides a mapping to the previous version, GAMP 4. It specifically provides:
1.
2.
3.
4.
5.
6.

Summary of Need for GAMP 5
Overview of GAMP Documentation Structure
GAMP 5 Main Body Structure
GAMP 5 Appendices
New and Revised Material
GAMP 4 to GAMP 5 Mapping

1 Summary of Need for GAMP 5
The GAMP Guide has been significantly updated to align with the concepts and terminology of recent regulatory and industry developments.
These regulatory and industry developments focus attention on patient safety, product quality, and data integrity. This is a key driver for GAMP 5.
Coupled to this there is the need to:






Avoid duplication of activities (e.g., by fully integrating engineering and computer system activities so that they are only performed once)
Leverage supplier activities to the maximum possible extent, while still ensuring fitness for intended use
Scale all life cycle activities and associated documentation according to risk, complexity, and novelty Recognize that most computerized systems are now based on configurable packages, many of them networked
Acknowledge that traditional linear or waterfall development models are not the most appropriate in all cases

© Copyright ISPE 2008. All rights reserved.

Page 1 of 10

2 Overview of GAMP Documentation Structure
The GAMP Guide forms part of a family of documents that together provide a powerful and comprehensive body of knowledge covering all aspects of computerized systems good practice and compliance. This Guide comprises a Main Body and a set of supporting Appendices.
The Main Body provides principles and a life cycle framework applicable to all GxP regulated computerized systems.
Practical guidance on a wide range of specific topics such as...

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