Pharma IT Insights

How could EudraLex Volume 4, Chapter 9 evolve to reflect modern GMP audit practice?

Torben Elhauge shares his proposal for a risk-based approach to internal and supplier audits, with stronger links to CAPA, management review and continual improvement.

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 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

This Insight is part of our AI in Pharma Series, where we share use cases for AI & automation in a highly regulated reality. With the ongoing migration from the eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD) to the Product Management Service (PMS), companies face the added challenge of ensuring seamless data integration and synchronization. In this Insight, we delve deeper into the challenges of meeting these regulatory demands and present an automated AI solution to solve them.

This Insight, written by Pharma IT Director of Regulatory Affairs (RA) Anne Louise Kirkegaard, highlights the importance of a solid RA strategy for small pharma and biotech companies. Plus tips to ensure market success and compliance.

This Insight, written by Pharma IT Cybersecurity expert Steen Lindebjerg provides a high level overview of the EU’s NIS2 Directive, including key changes in the old NIS legsilation and steps to take towards compliance.

This Insight is part of our AI in Pharma Series, where we share use cases for AI in a highly regulated reality. Pharma IT’s Director of Commercial & Medical Consulting discusses the use of AI in the commercial stage of the pharmaceutical life cycle. This includes use cases in promotional content ideation, creation, review, and approval.

This Insight describes the 3 main types of automation being used to increase the efficiency of pharmacovigilance and safety case processing! Learn about RBA, RPA, and AI.

This Insight describes the similarities and differences between CMC and GMP. Both are crucial to guarantee drug product quality, safety, and consistency.

Microsoft Word is a widely utilized tool for creating and editing regulatory documents. However, its full potential is often overlooked. In this Insight, Principal Medical Writer Katja Heinemeier provides 5 Microsoft Word Hacks for regulatory writers to increase writing speed & efficiency.

In this Insight, Jakob Juul Rasmussen highlights the recently released EMA Guideline on computerised systems and electronic data in clinical trials. The Insight includes a high-level overview of what’s included in the new guidance and background context for its adoption.