Use of Artificial Intelligence and Machine Learning (AI/ML)
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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Release of the FDA Draft Guidance “Computer Software Assurance for Production and Quality System Software”: Key Notes
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Release of the FDA Draft Guidance “Computer Software Assurance for Production and Quality System Software”: Key Notes

INTRODUCTION Recently, the Compliance and Quality team at the CDRH of the FDA issued the long-awaited draft guidance: “Computer Software Assurance for Production and Quality...

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ISPE │ GAMP5 – A Risk-based Approach to Compliant GxP Computerized Systems, Second Edition: Presentation of the Major Changes
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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What’s New in GAMP5 Edition 2?
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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