RQA 2025 International Conference
We are delighted to once again be a Silver Sponsor at the 2025 RQA Annual Conference where you can explore the future of quality. The conference will examine how real-world challenges demand practical, people-centered solutions. Dive into topics like Sustainability and Quality, Quality Tools that Work, and Beyond Metrics: Measuring What Truly Matters in Quality, […]
The Helsinki Declaration 2024 Update: Advancing Ethical Standards in the Era of Digital Clinical Research
The 2024 update offers important clarifications for pharmaceutical sponsors, clinical research organizations (CROs), and biotech innovators navigating the increasingly digital clinical trial landscape. Read more here
The Evolving Landscape of Pharmacovigilance IT: Key Considerations for the EU Regulation Amendment
The European Commission’s draft amendment to Implementing Regulation (EU) No 520/2012 introduces significant updates to pharmacovigilance requirements, with far-reaching implications for IT quality assurance in the pharmaceutical industry. These changes will extend well beyond computer system validation (CSV) to include data governance, data integrity, and comprehensive audit strategies. Full article here
Advancing Pharmaceutical Protocols: How ICH M11 CeSHarP Transforms Digital Compliance
The pharmaceutical industry is undergoing a significant transformation with the adoption of the International Council for Harmonisation (ICH) M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP) standard. This technical specification, updated in March 2025, represents a pivotal shift in how clinical trial protocols are structured, managed, and exchanged across global regulatory environments. Read more here
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 […]