Terms of Governance

Model use is fully disclosed across all review workflows. Every model call is prompt-versioned and logged on every finding. PHI is scrubbed before any model receives a case. Models surface medical evidence; they never sign or render official regulatory decisions.

Assigned medical reviewers may accept, edit, or reject any validator finding. When a reviewer acts, the entry of a decision rationale is recorded. No deletion of records is permitted — corrections and updates are appended, ensuring history is preserved and cases remain fully reconstructable.

Zen Health is designed to support 21 CFR Part 11 signature-manifestation and audit-trail requirements. Formal customer validation (IQ/OQ protocols) under their own SOPs is supported for regulated production use.

Safety database connectors (Oracle Argus, ArisGlobal, Veeva Safety) and clinical trial protocol pipelines follow validated deployment standards. All enterprise client engagements include comprehensive release documentation, formal validation deliverables (URS/FS/Traceability), and operational SLAs.

Zen Health functions strictly as clinical safety decision support software. The platform does not render autonomous medical diagnoses or patient treatment decisions. Final clinical judgments and regulatory submission filings remain the sole responsibility of credentialed physician reviewers of record, principal investigators, and trial sponsors.

Continuous protocol monitoring operates on high-availability infrastructure with 99.9% uptime commitments. Real-time safety signal alerts (e.g., Grade 3+ CRS/ICANS or Dose-Limiting Toxicity events) are dispatched to the designated reviewer queue immediately upon data normalization.

For questions regarding system governance rules, reviewer accountabilities, or operational SLAs, please contact our medical governance team.