See what a validation package looks like when it builds itself
A short walkthrough of how GxPForge keeps traceability current as your team works, instead of reconstructing it before a release.
Book a demoChange control is the process that keeps a validated system's evidence accurate after go live. Every meaningful change needs an assessment of impact, a decision about what revalidation is needed, and a record of that decision, before the change ships, not after.
Validation proves a system works as intended at a point in time. Every change afterward has the potential to invalidate that proof, in ways ranging from trivial to serious. Change control is the mechanism that decides, deliberately, which changes need fresh evidence and which do not.
The most common failure is treating change control as a formality, a form filled in after the fact to document a change that already shipped, rather than a gate that happens before the change goes live. A change control record dated after the change was already in production is a clear signal to an auditor that the process is not actually controlling anything.
Not every change needs the same depth of review, a cosmetic label update does not carry the same risk as a change to how data is calculated. The assessment itself should be proportional, but the decision to skip deeper review needs to be documented and defensible, not just assumed.
A short walkthrough of how GxPForge keeps traceability current as your team works, instead of reconstructing it before a release.
Book a demo