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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Kneat 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...
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Quality 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...
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Release of the FDA Draft Guidance “Computer Software Assurance for Production and Quality System Software”: Key Notes
INTRODUCTION Recently, the Compliance and Quality team at the CDRH of the FDA issued the long-awaited draft guidance: “Computer Software Assurance for Production and Quality...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
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?
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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CAI Named AIBF All-Star Multinational Of The Year 2022
Leading Multinational Achieve Top Irish Business Accreditation CAI Named AIBF All-Star Multinational Of The Year 2022 Leading global engineering, technical and consulting company CAI have...
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CAI’s Kneat Gx System Qualified & Released for Use
June 17, 2022Indianapolis, IN Following the initial development of a strategic partnership with Kneat Solutions in early 2022, CAI has today confirmed its status as...
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Medical Device Single Audit Program (MDSAP)
A quick primer Regulatory and quality compliance across multiple markets can be challenging for medical device manufacturers when scaling globally. This usually requires multiple dedicated...
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CAI joins “Orchards in the Community” to plant 1000 orchards across Ireland
DUBLIN, IRELAND - CAI is pleased to announce its participation in Host in Ireland’s “Orchards in the Community” initiative. Orchards play a key role in...
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