ISPE GAMP ® 5 (Second Edition) coming soon!

Coming Soon: July 2022 

GAMP® 5 (Second Edition)

Maintaining the principles and framework of the First Edition (2008), GAMP® 5 (Second Edition) is newly revised and expanded to address the increased importance of:

  • service providers;
  • evolving approaches to software development;
  • and the more widespread use of software tools and automation.

It highlights the use of Critical Thinking by knowledgeable and experienced SMEs to define appropriate qualification and validation approaches.

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