Trust & Evidence
Built to be audited.
Aegivance is engineered for medical reviewers, QPPVs, and the inspectors who will eventually walk through the case file.
What's available under NDA.
Five artifacts that document how Aegivance is designed, validated, and governed. Delivered to qualified prospects under NDA within 5 business days.
Evidence Chain Architecture
Per-tenant hash-chained integrity log. Tamper-evident by construction. Verifiable via the platform's verification endpoint. The architectural design record covers genesis rows, chain-sequence numbering, compensating events, and cross-tenant isolation.
21 CFR Part 11 Statement
Mapping of Aegivance controls to FDA Part 11 requirements. Closed-system controls, audit trail immutability, role-based access. Includes the open gaps we're transparent about — and the roadmap to close them.
IQ Protocol (Installation Qualification)
Source-code integrity verification, dependency installation, database schema state, environment variables, secrets management. Seven qualification steps with sign-off fields for deployment teams.
OQ Protocol (Operational Qualification)
Functional validation across eight major capabilities: authentication, ingestion (4 formats), the review engine, medical analysis, review workflow, E2B(R3) export, audit integrity, multi-tenant isolation. Twelve test scenarios with expected results and evidence-capture requirements.
Model Governance Policy
What models do and don't do. Specific model call sites, each prompt-versioned. PHI scrubbing contract. Provider flexibility (cloud-hosted in customer VPC or direct API). Human-in-the-loop boundaries. Failure-mode handling.
The Evidence Chain
Tamper-evident by construction.
Every regulated event in Aegivance — case ingestion, validation run, reviewer decision, approval, export attempt, evidence-pack generation — writes a row to a per-tenant integrity log.
Each row's record hash is computed from its contents plus the previous row's hash. To tamper with any historical row, every hash from that row forward would have to be recomputed — and our verification endpoint detects it on the next sweep.
Cross-tenant verification is blocked at the database layer. The chain for one tenant cannot link to or be modified by another.
Hard limits, by design
What Aegivance does not do.
- ×No automated regulatory submission.
- ×No model signs a case.
- ×No deletion of records — corrections are appended.
- ×PHI is scrubbed before any model receives a case.
Request the validation pack.
All five artifacts above, delivered under NDA within 5 business days. We'll respond to scope the depth of review your team needs.
Request Access