Use of Artificial Intelligence and Machine Learning (AI/ML)

December 8, 2022 || Laurent Saugrin
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 computerized systems, second Edition: PRESENTATION OF THE Major Changes” released in October 2022. INTRODUCTION The broad scope of digital health includes categories such as health…

ISPE │ GAMP5 – A Risk-based Approach to Compliant GxP Computerized Systems, Second Edition: Presentation of the Major Changes

September 1, 2022 || Eric Collier and Laurent Saugrin
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 A Risk-Based Approach to Compliant GxP Computerized Systems guide. This article lists these changes, and points to the applicable sections and/or appendices that have been…

What’s New in GAMP5 Edition 2?

August 22, 2022 || Eric S. Collier
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 if you’re under age 50.)  The Second Edition of GAMP5 is out!  My colleagues and I have had a chance to review and will be…