Audit Trail
21 CFR Part 11 · immutable · WHO / WHAT / WHEN / WHY / WHERE
Compliance score
94%
WCAG-aligned trail
Entries (30d)
2,847
+312 vs last 30d
Critical actions
47
all signed
Failed integrity
0
no tampering detected
Activity Log
Latest 40 entries · sorted by timestamp desc
2026SIGNL. BrownMonitoring Visit Report·Visit complete · 6 findings closed10.42.18.7
2026UPDATEL. BrownSubject·SDV — corrected lab value transcription10.42.18.7
2026CREATEL. BrownQuery·Visit window deviation — V5 missed 7-day window10.42.18.7
2026APPROVEL. BrownAI Finding·ICF v4.2 re-consent overdue · accepted as deviation10.42.18.7
2026CREATEwrldos.aiAI Finding·Pattern detection — 2 subjects pre-Mar 12 lacking re-consentinternal
2026SIGNDr. J. ReyesInformed Consent·v4.2 re-consent obtained10.42.18.21
2026UPDATEK. Williams (RN)Vital Signs·Day-7 visit · BP 142/88 entered10.42.18.21
2026EXPORTL. BrownSDV Report·Pre-visit briefing10.42.18.7
2026UPDATEwrldos.aiRisk Score·Daily site risk recalculation · 38→42 (medium)internal
2026LOCKS. ParkSubject·Subject completed · final visit signed10.42.18.34