DecisionRecord
Cou1 overall
https://uofa.net/morrison-v09/decision/cou1-overall
Described in
packs/vv40/examples/morrison-v09/cou1/uofa-morrison-v09-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 |
uofa:decisionProvenance |
extracted |
uofa:decisionAnchor |
{"type":"SourceAnchor","anchorLocator":"archive://morrison/source/decision_rationale_cou1.pdf","anchorSha256":"sha256:01190eb07629faf0b83aa29c3dd2829d599137f70f1f9446c87c1970bb7eb211"} |
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.
| Record | Property | Source |
|---|---|---|
https://uofa.net/morrison-v09/cou1 |
uofa:hasDecisionRecord |
uofa-morrison-v09-cou1.jsonld |