Unit of Assurance

DecisionRecord

Cou1 overall

https://uofa.net/morrison/decision/cou1-overall

Described in packs/vv40/examples/morrison/cou1/uofa-morrison-cou1.jsonld

Fields

@type DecisionRecord
uofa:role Credibility assessment team
uofa:outcome Accepted
uofa:rationale Model deemed sufficiently credible for COU1. All verification goals achieved at or above target gradation levels. Validation comparison at all 5 operating conditions shows hemolysis index below CPB predicate threshold (RH < 1). No formal CFD uncertainty quantification performed for COU1 (addressed by W-AL-01 weakener).
uofa:decidedAt 2019-02-01T00:00:00Z

References

uofa:actor https://uofa.net/org/FDA-CDRH

Referenced by

Which records point at this identifier, and through which property. This relationship is not written down anywhere in the packages themselves; it is derived by indexing the whole corpus.

RecordPropertySource
https://uofa.net/morrison/cou1 uofa:hasDecisionRecord uofa-morrison-cou1.jsonld