Blog

Kneat and CAI:  Building the Future of Validation Together

October 24, 2022 || Jon Thompson
 
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 Roth, Associate Director, Global C&Q, CAI.  The webinar can be found here:  https://kneat.com/webinars/.  This title perfectly sums up the growing relationship that was formalized just…

Quality Mindset on High-Risk Projects

October 7, 2022 || Lana Caperton
 
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 throughout the process.  Drivers for client projects include getting drug product to more patients at a lower cost (expansion of new process trains and scale…

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…

CAI Named AIBF All-Star Multinational Of The Year 2022

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…

CAI’s Kneat Gx System Qualified & Released for Use

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…

Medical Device Single Audit Program (MDSAP)

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…

CAI Announces Investment in Groundbreaking Hazardous Energy Management Solution, autoLOTO

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…