The Evolution of IT Quality and Validation in Clinical Trials Part 1
The clinical trial landscape has undergone significant transformation with digital technology becoming increasingly central to trial design, data collection, and management. The recently updated International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6(R3) guideline, adopted in December 2024 and coming into effect July 2025, represents a major evolution in how regulatory bodies expect sponsors […]
Matt Jones appointed Chair of the RQA Board of Directors
We are delighted to announce that Matt Jones has been appointed Chair of the Board of Directors of the Research Quality Association (RQA). In accepting the position, Matt said ‘Accepting the RQA Chair position holds deep personal significance. Having served as IT Committee Chair, I now follow in the footsteps of my first boss – […]
The New Imperative: IT Supplier Quality Assurance Under ICH E6(R3)
As the July 2025 implementation date for ICH E6(R3) approaches, a significant evolution in regulatory expectations is becoming clear. Discussions at the recent ACT Workshop confirmed what many quality professionals have anticipated: regulatory authorities are intensifying their focus on IT service provider oversight, and eliminating the current gap of not conducting direct routine inspections of IT […]
Are you still thinking ITQA is just about CSV? Think bigger!
In today’s complex pharmaceutical landscape, Computer System Validation is just one piece of a much larger puzzle. The digital transformation of pharma demands a holistic approach to IT Quality Assurance that encompasses your entire technological ecosystem. Don’t let outdated perceptions limit your ITQA potential. Partner with experts who understand the intricate dance between innovation and […]
Mission: Quality Is Possible
We are delighted to be a sponsor at the 2025 European Virtual QA Conference which takes place between the 20th and 22nd May 2025. This fully virtual event runs from 08:00 to 17:00 BST each day, and will bring together auditors, quality managers, and regulatory professionals across Europe. This year’s theme is Mission: Quality Is Possible, and the programme will include: To find out […]