Articles from practice

The revised guideline on good clinical practice has applied in the EU since July 2025, and its Annex 2 follows on 15 January 2027. It no longer treats computerised systems as a side issue but as part of the data responsibility of sponsor and trial site. This article sets out what E6(R3) requires of software in clinical trials, what Annex 2 adds for wearables, apps and data from routine care, and how to align the effort with the risk.

In regulated environments, software must be validated — and many teams experience this as a mountain of paperwork that slows every small change. It need not be so. The risk-based approach has been the state of the guidelines for years: effort where the risk sits, and restraint where there is none. This article shows what validation really requires and how GAMP 5 and EU GMP Annex 11 support the lean route.

An AI pilot promises quick wins and is still stuck months later. The cause is rarely the model, but the data beneath it: inconsistent keys, duplicates, missing units. This article describes why data maturity is the actual project — and when AI honestly does not help.