Analysis & knowledge

Articles & Whitepapers

In-depth analysis and practical guidance, with references to the regulation instead of buzzwords.

16 entries

Article18 Jun 2026

Computer System Validation: Two New Standards, One 12-Week Window

The revised Annex 11 is in final consultation. Annex 22 sits alongside it in draft: the EU's first dedicated guidance on AI in GMP manufacturing. Read them side by side and the message is the same. The bar for trusting a computerised system is moving up.

Article11 Jun 2026

AI-Driven Inventory Optimisation: Consolidating Redundant Stock Without Touching the ERP

In pharma and MedTech warehouses, duplicated, technically identical items tie up capital and space without showing up in the ERP. How feature-based consolidation with AI makes redundant stock visible, without any intervention in the validated system.

Whitepaper10 Jun 2026

MDR Meets the EU AI Act: The Trilemma for AI Software

AI software that qualifies as a medical device must satisfy the MDR and the EU AI Act at the same time. The costly mistake is not the second regulation, but running two separate worlds of documentation. Where MDR classification and AI Act high-risk status interlock.

Article2 Jun 2026

What manual visual inspection really costs

We fully costed a completed AVI project: 89 inspectors replaced by two automated systems, 4.2 million euro in annual savings, ROI in around 2.5 years.

Article2 Jun 2026

The EU AI Act for Life Sciences: When AI Counts as High-Risk

Whether AI in a medical device or IVD counts as high-risk AI is decided not by the technology but by the conformity assessment route under the MDR or IVDR. How Art. 6 of the EU AI Act triggers the classification and which application dates matter.

Article28 May 2026

CDMOs as Strategic Partners: From Capacity Provider to Co-Creator of Value

The pandemic has recalibrated the role of CDMOs. Those who only sell capacity remain interchangeable; those who bring together digitalisation, joint planning and resilience become strategic partners. The four building blocks of this transformation and what they mean for partner selection.

Article20 May 2026

FMEA or FTA? Why Choosing the Method Will Not Save Your Risk Analysis

In many MedTech projects, the first question is which method to use for the risk analysis. That question falls short: quality is not determined by the method, but by the fit between the question, the method, and integration into the logic of ISO 14971.

Article14 May 2026

Regulatory Intelligence: Not the Best Tool, but the Right Fit

When selecting a regulatory intelligence solution, success is not determined by the range of features, but by the fit with your own regulatory context. Why feature lists are misleading and which four dimensions actually decide the outcome.

Article12 May 2026

From Regulatory Text to Requirement: How Annex 11 Becomes Testable Audit Trail Specifications

What an audit trail must deliver is set out in Annex 11, 21 CFR Part 11 and the data integrity guidelines. What this means for a specific system is not. How a single regulatory paragraph can be translated into testable user requirements using qualitative content analysis.

Article6 May 2026

CSV Does Not End at Qualification: Periodic Review and Change Control as Common Findings

Many computerised systems are cleanly qualified at go-live and then left to their own devices. That is exactly where the major findings arise: missing periodic reviews and a gap-ridden change control history under EU GMP Annex 11.

Article15 Apr 2026

EUDAMED Readiness: Why Registrations Fail in Practice

Since 28 May 2026, vigilance reporting, PSUR and PMSR must be submitted through EUDAMED. Companies without complete actor and UDI registration can no longer formally meet their statutory reporting obligations. Four problem clusters we encounter time and again.

Article8 Apr 2026

From Lab to Production: The Five Critical Challenges of Biotech Scale-up

Good science is not enough. Anyone seeking to take a biological process from laboratory to industrial scale runs into five challenge clusters that have to be solved simultaneously - technically, commercially and operationally. Where this fails in practice and how the transition succeeds.

Article2 Apr 2026

Agile or Waterfall? Why Pharma Projects Must Align the Method With the Question

Whether waterfall or agile is the right approach is not decided in pharma projects by method preference, but by the regulatory character of the undertaking. Where validation-driven projects need structure, where digitalisation benefits from iteration, and why the hybrid approach usually wins.

Article26 Mar 2026

Leadership Gap 2035: The Quiet Turning Point in Pharma Leadership

Less visible than AI or new therapies, but strategically just as consequential: by 2035 a large part of today's generation of leaders will leave the pharmaceutical industry. Where the gap arises and the six fields of action with which companies can close it.

Article18 Mar 2026

Effective GxP Audit Preparation: Weak Points, Mock Audits, CAPA Maturity

Most audit findings do not arise from the fine detail of a single regulation but from recurring structural gaps: superficial root-cause analysis, unverified data integrity, a supplier program that is not risk-based. Recognising these patterns before the inspection lets you close the gap while there is still time to do so.

Whitepaper15 Mar 2026

AI in Medical Technology: AI Act, MDR and IVDR in Combination

When does AI software qualify as a medical device? What requirements does the AI Act place on high-risk systems? And what do the current deadlines mean concretely for manufacturers? This whitepaper structures the regulatory complexity and translates it into options for action.

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