Chain-of-Custody for
Medical & Regulatory Documents
Clinical trial documents, research datasets, and regulatory submissions demand strict chain-of-custody. Diogenes maps directly to 21 CFR Part 11 requirements for attributable, tamper-evident, time-stamped electronic signatures.
Regulatory Compliance Demands Provable Integrity
Healthcare and pharmaceutical organizations face stringent requirements for document integrity. Current systems rely on proprietary platforms with limited auditability, creating risk when regulators demand proof of chain-of-custody.
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21 CFR Part 11 requires attributable, tamper-evident electronic signatures with timestamps. -
Proprietary e-signature platforms create vendor lock-in and limited audit transparency. -
Cross-institutional document workflows lack standardized provenance infrastructure.
21 CFR Part 11 Alignment
Purpose-Built for 21 CFR Part 11 Compliance
Document Integrity
Documents never leave your network. Only cryptographic hashes are transmitted for verification, ensuring complete data sovereignty while maintaining provable integrity.
Multi-Party Sign-Off
The attestation DAG captures every sign-off in the approval chain -- principal investigator, clinical monitor, quality assurance, regulatory affairs -- each as an independent, verifiable attestation.
Audit-Ready Trail
The transparency log provides a complete, tamper-evident record that regulators can independently verify. No reliance on the submitter's own records.
How Diogenes Compares
Regulated industries need more than "someone signed this." They need provable identity, tamper-evident audit trails, and independence from any single vendor's infrastructure.
| Capability | Proprietary eSign Platforms | PKI / CA-Based Systems | Diogenes |
|---|---|---|---|
| 21 CFR Part 11 alignment | Vendor compliance claims | Certificate-based, rigid hierarchy | Attributable, tamper-evident, time-stamped, auditable by design |
| Cross-institutional workflows | Requires same vendor | Cross-CA trust is fragile | Federated trust via endorsement graphs |
| Audit independence | Vendor provides the audit log | CA controls revocation lists | Public transparency log, regulator can verify independently |
| Data sovereignty | Documents stored on vendor servers | Certificates centrally issued | Self-hosted, only hashes leave your network |
| Multi-party sign-off chain | Sequential signature routing | Not supported | Attestation DAG with independent role-based verification |