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Glossary Entry

Delta validation

Validation approach where only the changed portion (delta) of a digitized process / recipe is assessed and documented – not the entire chain.

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: