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Articles tagged with “fhir-provenance”

FHIR Provenance vs AuditEvent: GxP Traceability Matrix

FHIR Provenance vs AuditEvent for GxP in 2026: a scenario crosswalk of 11 events, version and signature limits, Part 11 and Annex 11 context, retention anchors, and four test ratios.

29 min read

10/27/2026

fhir provenance vs auditevent fhir provenance fhir auditevent gxp traceability 21 cfr part 11 audit trail annex 11 alcoa data integrity ihe balp atna clinical trial data lineage