Context: Traditional full validations slow iteration. Delta validation enables shorter cycles without regulatory gaps.
Why it matters: Cuts time & cost per change; increases change frequency & learning curve.
Prerequisites:
- Fine-grained versioning.
- Complete audit trail.
- Clear functional impact segmentation.
Limits: Not suited for safety-critical core logic or fundamental architecture shifts.
Example: Adjusting a mixing time parameter → validate only parameter impact & updated risk assessment.
Further reading: