Audit Logs
Complete audit trail for 21 CFR Part 11 compliance
Total Entries
91,847
All time
Today
342
+18% vs avg
Agent Actions
187
54.7% automated
Human Actions
155
45.3% manual
Alerts
3
Requires review
All MedDRA coding verified. Causality assessment consistent with label. Approved for regulatory submission.
Deterministic classification: Serious (hospitalization criteria met), Unlisted (not in RSI v4.2), Expedited reporting required per ICH E2D.
Primary agent causality: Probable. Validation agent causality: Possible. Mismatch detected → workflow locked → escalated to human reviewer.
Updated reaction outcome from 'Not Recovered' to 'Recovering' based on follow-up information received via email.
E2B(R3) XML generated for EMA submission. ICSR format validated against ICH E2B(R3) schema. File: E2B_PV-2024-00843_v1.xml
Insufficient reporter information. Missing: reporter contact details, qualification verification. Returned to intake for follow-up.
Multi-factor authentication completed. Session established. IP: 192.168.1.xxx. Device fingerprint verified.
ICSR submitted to FDA via E2B gateway. Tracking ID: FDA-ACK-2024-88412. 15-day expedited deadline met (3 days remaining).
New follow-up information received from reporter. Case reopened for processing. Previous version archived as v2.
PII/PHI fields redacted before AI processing. Fields masked: patient name, DOB, address, phone. De-identification verified.