TENVIA · REVIEW RESOURCE
Your Tenvia supplier review checklist
Use this checklist to organise your review. It helps you plan what to ask. It does not confirm that a safeguard has been checked or that a document is available.
| Area | Confirm and record |
|---|---|
| Service scope | Studies, users, intended use, document inputs, outputs and acceptance criteria. |
| Identity and access | SSO/MFA requirements, roles, study membership, external collaborators and access removal. |
| Data handling | Hosting region, providers, permitted data, retention, deletion, return and transfer terms. |
| AI governance | Models and providers, permitted uses, training restrictions, source history, testing and human review. |
| Historical evidence | Original/amended versions, source rights, lineage, missing coverage and distinction between documented reason and inference. |
| External design reviewers | Investigator/site and patient/public invitations, identity, limited content, expiry, revocation, privacy review and version-specific responses. |
| Design preflight | Eligibility and timing-rule clarity, critical-to-quality questions, checked documents, missing coverage, exact source versions and responsible specialist. |
| Site and technology feasibility | Resource, result-turnaround, visit-window, system/login/training and duplicate-entry assumptions; actual site responses and unknowns. |
| Review and decision governance | Overlapping specialist roles, required reviews, disagreements, version binding and approval authority. Confirm that material changes invalidate affected sign-offs. |
| Amendment execution | Impact on manuals, SoA, data rules, patient material, site applicability, role-specific briefings, separate approvals and training evidence. |
| Standards and handoff | Pinned M11/USDM versions, supported elements, lossy mappings, vendor destination acceptance and semantic readback evidence. |
| Future study learning | Permitted organisation/study history, observation definitions, denominators, corrections and access revocation. No default cross-customer pooling. |
| Security | Architecture, testing evidence, incident contacts, recovery and evidence disclosure arrangements. |
| Quality | Intended-use assessment, supplier evidence, customer validation and change-control responsibilities. |
| Commercial and support | Contracting parties, platform/study scope, onboarding, support hours, response commitments and escalation. |
| Exit and handover | Record ownership, output formats, return/deletion and outstanding study responsibilities. |