Baseline — from FAT to SAT, without re-testing what didn't change.
A global manufacturer was repeating full validation campaigns at every phase boundary. Test plans executed at the vendor's factory (FAT) were re-executed verbatim on site (SAT), because nobody could prove what had — or hadn't — moved in between.
- 01VEM integrated on the production-island bench during FAT to capture a signed baseline.
- 02Baseline carried with the asset to site; re-baselined at SAT start.
- 03Compare report attached to the validation package as objective evidence of equivalence.
- 04Continuous monitoring throughout SAT execution; every drift attributed in real time.
- >70%
- reduction in test execution
- 13.5 wk
- saved on one packaging line
- 32 → 8
- SAT test plans required