Pharma IT consultants are acutely aware of the challenges that pharma, biotech, and medical device companies face

In this Pharma IT insight, Torben Elhauge, Director of CMC, examines the key changes introduced in the revised EudraLex Volume 4, Chapter 4 on GMP documentation. Drawing on more than 25 years of pharmaceutical experience, he outlines how the updated chapter expands expectations around data governance, risk management, data integrity, hybrid and electronic systems, and AI-generated data. From the introduction of ALCOA++ principles to stronger links with Annex 11, Annex 22, and Chapter 6, Torben shares practical considerations to help organizations assess their documentation processes and strengthen compliance with the updated requirements.

In this exclusive Pharma IT feature, Rojan Demirtas, Director of Manufacturing, explores the evolving landscape of Commissioning, Qualification, and Validation (CQV) in complex CAPEX projects. From risk-based validation strategies and stakeholder alignment to the impact of cloud technologies and AI on GMP environments, he shares practical insights on achieving consistency, improving quality outcomes, and building strong project foundations that support long-term success.

Nick Larsen, Pharma IT’s Director of Data, AI & Migrations, recently joined Peter Vester, Lead Data Scientist at Novo Nordisk, on the Life Science BusinessReview.dk Podcast. Together, they explored how AI is shaping the future of Life Science from data compliance to unlocking innovation through responsible AI adoption.