Insights

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.

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.

DevOps offers faster delivery and collaboration, but in regulated GxP environments it must be adapted for traceability and control. This Insight explores how pharmaceutical companies can integrate QMS and DevOps to achieve true continuous delivery.

Artificial intelligence is reshaping life sciences, but expectations often exceed reality. Success requires strong data foundations, governance, and compliance. Learn how companies can move from AI hype to practical value, turning innovation into measurable results while reducing risk and ensuring regulatory alignment.

As demand for biologics surges, biopharma manufacturers face a critical hurdle: scaling operations amid a growing talent shortage. In Denmark and across the Nordics, a lack of specialized expertise slows tech transfer, validation, and regulatory readiness. Discover a three-tiered solution—training, coaching, and expert support—to scale with confidence.

Data migration in life sciences is no longer a one-time headache—it’s becoming a continuous, AI-assisted capability. Learn how life science organizations are moving from disruptive, high-risk projects to repeatable, GxP-compliant data pipelines that keep systems updated and insights flowing. Ready to make migration part of your digital routine?

This Insight explores the impact of EcoVadis Ratings on procurement decisions in the life sciences. Director of Sustainability, Communications, and Culture @Naomi Jade Kellogg breaks down why EcoVadis matters, how it’s shaping procurement, and what suppliers can do to boost their ratings and stay ahead.

Pharma IT Insights Drug-Device Combination Products and the Impact of the EU MDR By Anne Louise Kirkegaard February 9, 2025 Pharma IT Insights Drug-Device Combination Products and the Impact of the EU MDR By Anne Louise Kirkegaard February 9, 2025 ← Back to Insights Share on email Share on linkedin Share on facebook Share on …

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