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Guide to GAMP 5 vs GAMP 5 2nd edition

This guide will give you a complete overview of what has changed in the second edition of GAMP 5 in comparison to its predecessor.

GAMP5 vs GAMP5 2nd edition | Scilife

What's inside?


In this guide, you will find a comprehensive recap of:

  • The structure of GAMP 5 2nd edition, the purpose of its sections and appendices.
  • An overview of the new edition and its alignment to the Agile 2 approach and current industry practices.
  • Significant changes to terminology and approaches to align with modern technologies and risk based thinking.
  • Appendices from the previous edition that have been removed from the new version.

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