Built to be audited.
Zen Health is engineered for medical reviewers, QPPVs, biostatisticians, and the regulatory inspectors who will eventually examine the case file and protocol history.
What's available under NDA.
Five comprehensive validation packages documenting how Zen Case AI and Zen Protocol AI are designed, validated, and governed. Delivered to qualified prospects under NDA within 5 business days.
Evidence Chain & Data Integrity Architecture
Per-tenant cryptographic hash chain for data integrity. Tamper-evident by construction with immutable append-only ledgers that prohibit retroactive modification of audit records, reviewer decisions, and electronic signatures.
21 CFR Part 11 & GxP Compliance Statement
Mapping of Zen Health controls to US FDA 21 CFR Part 11 and EU Annex 11 requirements. Electronic signatures with OTP re-authentication, audit trail immutability, role-based access, and system boundary specifications.
ICH M11 & USDM Protocol Traceability Matrix
Validation protocol mapping Zen Protocol AI authoring and conversion outputs across all 133 ICH M11 harmonized sections, USDM data structures, and cross-section dependency impact tracking.
Monte Carlo Statistical Verification Protocol
Mathematical proofs and validation test suites verifying the statistical accrual kernel against standard biostatistical modeling benchmarks (Poisson-Gamma distributions and patient dropout rates).
AI Governance & De-Identification Policy
Model evaluation protocols, version-controlled clinical prompt registries, automated PHI/PII de-identification pipelines, and non-authoritative clinical decision support boundaries.
Tamper-evident by construction.
Every regulated event in Zen Health — case intake, validation sweeps, physician adjudication, dual electronic signatures, protocol section generation, and export generation — writes an append-only row to an immutable audit ledger.
Each row's record hash is computed from its contents plus the previous row's cryptographic hash. Database triggers prohibit updating or deleting historical logs, preventing backdating or silent alterations.
Cross-tenant isolation is enforced at the database schema layer. Data chains for one sponsor or clinical site cannot link to or be accessed by another.
What Zen Health does not do.
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.