Change Control Management in validated operations

Our services for change control management

Technical change, formal evidence

Change control answers four questions verifiably: who changed what, when, on what grounds, and what effect that had on the validated state. That is different from Change Management, which takes people through a transformation. In GxP operations you need both.

This page addresses QA, system owners and equipment owners who have to keep the change backlog closed for laboratory instruments, production equipment or computerised systems. In inspections it is rarely the changes themselves that attract attention, but open changes without a closure record and modifications carried out without a change at all.

Impact assessment first

Every change starts with the question of whether and how it touches the validated state. The assessment determines the test scope: regression testing of affected functions, requalification of individual test points, or full revalidation. We document that derivation so it can be justified in an audit.

What we steer

Equipment changes across the full lifecycle, meaning procurement, requalification and retirement, plus changes to computerised systems and to validated spreadsheets. We work inside your quality system, for example TrackWise, Veeva Vault or SAP-based solutions, and follow your SOPs rather than a process of our own.

Coordination and closure

We stay with the change until tests, approvals and documentation are in place. One volume example is the change control for 70 lab PCs case story. On the network map this station sits in operations, next to System Review and CAPA.

Our approach in GxP projects: from planning through release – each step delivers evidence you can present in QA review and audit. View GxP consulting in five steps