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

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.

EMA Policy 70 has expanded significantly, requiring broad publication of clinical data to increase transparency and public trust. This article explains what the revised policy means, the challenges companies face when preparing redactions, and how organizations can turn compliance into a strategic advantage.