Nick Armstrong Named CAI’s Initial Senior Director of Digital Enablement
INDIANAPOLIS, Feb. 2, 2023 – Commissioning Agents Inc. (CAI) announced Nick Armstrong has been named the Initial Senior Director of Digital Enablement, as CAI continues...
Read MoreWesley Vestal Named CAI’s Chief People Officer; Joins Company Leadership Team
INDIANAPOLIS, Indiana, January 2, 2023 – Commissioning Agents Inc. (CAI) announced that Wesley Vestal has been named CAI’s Chief People Officer. In this role, Wesley...
Read MoreErik Adams Named Global Director of Program Project Management
INDIANAPOLIS, Indiana, January 3, 2023 – Commissioning Agents Inc. (CAI) announces Erik Adams named Global Director of Program Project Management (PPM). In this role, Erik...
Read MoreUse 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...
Read MoreKneat and CAI: Building the Future of Validation Together
Building the Future of Validation Together was the title of a recent webinar co-presented by Rick Mineo, Director of Strategic Partnerships at Kneat and Aaron...
Read MoreQuality Mindset on High-Risk Projects
From client project kick-off to ribbon cutting, a high-risk project can be controlled if quality behaviors and expectations are exercised and embraced by the Team...
Read MoreRelease of the FDA Draft Guidance “Computer Software Assurance for Production and Quality System Software”: Key Notes
INTRODUCTION Recently, the Compliance and Quality team at the CDRH of the FDA issued the long-awaited draft guidance: “Computer Software Assurance for Production and Quality...
Read MoreISPE │ 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...
Read MoreWhat’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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