Blog Post
Use of Artificial Intelligence and Machine Learning (AI/ML)
This article is the first of five (5) articles that fall under the umbrella of the paper “ISPE│GAMP5 – a risk-based approach to compliant gxp...
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Blog Post
Release of the FDA Draft Guidance “Computer Software Assurance for Production and Quality System Software”: Key Notes
INTRODUCTION Recently, the Compliance and Quality team at the CDRH of the FDA issued the long-awaited draft guidance: “Computer Software Assurance for Production and Quality...
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Blog Post
ISPE │ GAMP5 – A Risk-based Approach to Compliant GxP Computerized Systems, Second Edition: Presentation of the Major Changes
INTRODUCTION The scope of this article includes the major technical content changes that have been made in the newly released Second Edition of the ISPE│GAMP5...
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Blog Post
What’s New in GAMP5 Edition 2?
It’s here, it’s here! I’ve felt like Navin R. Johnson waiting for the new phone book to arrive. (You might have to Google this one...
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