Clinly Portal
Regulatory compliance, audit oversight & system administration.
21 CFR Part 11
✓
Compliant
ICH E6(R3)
✓
GCP Aligned
Audit Events
152
Immutable
Active Users
3
All verified
Last Backup
2h ago
Auto-backup ✓
System Health
Database (PostgreSQL)
● Healthy
Audit Trigger System
● Active
API Server
● 12ms avg
Session Management
● Secure
AI Protocol Parser
● Rate Limited
Audit Trail Overview
118
INSERT
32
UPDATE
0
DELETE
2
Studies
All 152 audit records are immutable and cryptographically protected. DELETE operations are prohibited at the database level. Each record captures old/new values, timestamp, user ID, and study context.
Recent Audit Events (All Studies)
| Timestamp | Action | Table | Study | Field | Old | New | User |
|---|---|---|---|---|---|---|---|
| 2025-03-01 14:32 | INSERT | form_data | FLAURA2 | weight_kg | — | 72.4 | system |
| 2025-03-01 14:31 | UPDATE | form_data | FLAURA2 | systolic_bp | 118 | 122 | system |
| 2025-02-28 09:15 | INSERT | form_data | FLAURA2 | creatinine_umol_l | — | 82.0 | system |
| 2025-02-05 10:22 | INSERT | form_data | PLANETTE | alt_u_l | — | 32 | system |
| 2025-02-05 10:20 | UPDATE | subjects | PLANETTE | current_visit | C1D15 | C2D1 | system |
Regulatory Compliance Checklist
✓Audit trail enabled & immutable (21 CFR 11.10e)
✓User access controls & roles enforced
✓Electronic signatures supported (gateway auth)
✓CDISC ODM export for regulatory submissions
✓Old/new value capture on every field change
✓GCP data validation via edit checks
✓SAS XPT / SDTM domain mapping available
◎E-signature audit pending full deployment