Release of the FDA Draft Guidance “Computer Software Assurance for Production and Quality System Software”: Key Notes
INTRODUCTION Recently, the Compliance and Quality team at the CDRH of the FDA issued the long-awaited draft guidance: “Computer Software Assurance for Production and Quality...
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...
Read MoreCAI 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...
Read MoreCAI’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...
Read MoreMedical 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...
Read MoreCAI 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...
Read MoreCAI Announces Investment in Groundbreaking Hazardous Energy Management Solution, autoLOTO
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...
Read MoreTurning Project Risks into Successes when Building an ATMP Facility
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...
Read More