A Practical GAMP5 Checklist for Laboratory System Validation

GAMP5's risk-based approach to Computer System Validation exists precisely to prevent CSV becoming a project bottleneck — yet in practice, many laboratory technology projects still treat validation as a final-stage formality rather than a design input.

The most efficient validation programmes we deliver start validation planning at the same time as solution design, not after go-live. This means defining User Requirements Specifications collaboratively with end users, conducting risk assessments early enough to influence configuration decisions, and building IQ/OQ/PQ test scripts directly from those requirements.

Change control is where many laboratories lose the benefit of a well-executed validation. A validated system that lacks disciplined change control quickly drifts out of its validated state. We recommend laboratories treat change control as a living process, reviewed at a defined cadence, not a document that's filed away after go-live.