Context: Not every change requires full revalidation. Change control and risk assessment define the testing scope – which shortens change cycles.
Why it matters: Cuts time & cost per change; the validated state must demonstrably be maintained.
Prerequisites:
- Defined change control procedure.
- Documented impact and risk assessment.
- Fine-grained versioning.
- Clear functional impact segmentation.
Limits: If the impact cannot be reliably delimited, or the change affects core logic or architecture, a broader testing scope is required.
Example: Adjusting a mixing time parameter within the validated process range → assessment in change control, targeted testing incl. regression, updated risk assessment.
Further reading: