GAMP 5 Guide 2nd Edition Released

ISPE has released its latest edition of the GAMP5 guide for the compliance and validation of GxP computerized systems

“Do you want a validated system, or a system that works?” This was a standing joke back in the days.

Applying the revised approach of GAMP 5 Second Edition, you can actually have both. The guidance contains many statements putting focus on real quality, such as, "This appendix has been revised to emphasize that testing by any means, and in any part of the life cycle, and in any environment (development, validation, production, DevOps, etc.), all contributes to finding defects and confirming the system is fit for intended use.”

If you're stuck on Computer System Validation principles of the past, be sure to check out the recently updated and published Edition 2 of the GAMP 5 guidance. In this edition, ISPE moves further away from the traditional concept of CSV. While the original guide already toned this down, Edition 2 is way more explicit. ISPE’s thinking is aligned with FDA, as expressed in the recently published draft of their long awaited Computer Software Assurance (CSA) guidance. While the CSA guidance is specific to the Medical Device area, it has been created in consultation with Center for Drug Evaluation and Research (CDER).

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Morten Friis
Principal Consultant

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