Document Vault
21 CFR Part 11 compliant document management with e-signatures
4
Total Documents
1
Pending Review
3
Approved
11
E-Signatures
| Document | Category | Version | Status | Uploaded | Size | Signatures | Actions |
|---|---|---|---|---|---|---|---|
Protocol v3.0 PDF | Protocol | 3.0 | approved | 8/8/2026 by Dr. Smith | 2.4 MB | 3 | |
Informed Consent Form PDF | ICF | 2.1 | approved | 8/5/2026 by Admin | 1.2 MB | 5 | |
CRF Template XLSX | CRF | 1.0 | review | 8/9/2026 by Data Manager | 856 KB | 1 | |
Safety Report Q3 PDF | Safety | 1.0 | approved | 7/31/2026 by Safety Officer | 3.1 MB | 2 |
21 CFR Part 11 Compliance
- • All documents are cryptographically signed with SHA-256 hashes
- • Complete audit trail maintained with timestamps and user identification
- • Electronic signatures legally binding and tamper-evident
- • Automatic version control with change history preservation