Blog
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…
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…
August 4, 2022 || David Shenberger
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 been named AIBF All-Star Multinational Of The Year 2022 by the All-Ireland Business Foundation. CAI help their customers design, deliver, operate and maintain quality-critical manufacturing…
June 17, 2022 ||
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 an official Kneat Platform Partner with the launch of its own validated Kneat Gx software instance. The Kneat Gx instance, which is a 21 CFR…
April 6, 2022 || Martina McDonagh
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 resources to support regulatory audit schedules from all the jurisdictions and can cause disruptions to day-to-day operations. If this applies to you, then MDSAP could…
March 17, 2022 || David Shenberger
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 providing an early food source for struggling bees. To help protect the bees and increase pollination, CAI is part of 52 pledgers and over 90…
February 25, 2022 || David Shenberger
INDIANAPOLIS, Feb. 25, 2022 /PRNewswire/ — CAI, a global consulting company that provides technical, operational consulting, and project management services to life sciences, data centers, and process manufacturing industries, today announced an initial $1.1M investment in autoLOTO to support bringing applications to market in critically underserved areas around construction and manufacturing. autoLOTO has transformed the construction life…
February 9, 2022 || Joe Micsko
Need for Speed is the name of the game when building a facility to manufacture ATMP products. With a heavy focus on an accelerated schedule and getting your product to market faster this brings unique risks. Converting some project risk factors into success factors could change your whole dynamic and…
November 22, 2021 || Connie Leech
When it comes to being prepared for an inspection from a regulatory authority, the combination of preparation and practice will often make the difference between success and failure. Regulatory Inspections are becoming increasingly complicated, comprehensive, and higher expectations are required based on the restrictions caused by the COVID 19 pandemic.…
November 19, 2021 || David Shenberger
DUBLIN, Ireland., (17Nov2021)— CAI, a global consulting company that provides technical, operational consulting, and project management services to life sciences, data centers, and industrial process manufacturing industries, today announced that it is officially open for business in the UK. CAI is proud to now be able to serve clients in the…
