Your validation binder.
Pre-built.
AI Lab Services ships with a complete Vendor Validation Package — RTM, executed OQ test cases, IQ/OQ/PQ templates, and all required 21 CFR Part 11 documentation. Download it from the Compliance module. Hand it to your auditor.
What's in the Vendor Validation Package
Generated on demand from your Compliance module. Every document reflects the current system version with live test evidence — not a static PDF written three years ago.
Requirements Traceability Matrix (RTM)
Every 21 CFR Part 11 requirement mapped to the specific system control that satisfies it — with the test case that verifies it.
16 Executed OQ Test Cases
Live-system Operational Qualification test cases covering authentication, audit trail immutability, e-signatures, COA integrity, and access control — with pass/fail evidence.
IQ / OQ / PQ Templates
Pre-structured Installation, Operational, and Performance Qualification protocols. Fill in your site-specific data and sign.
§11.100(c) E-Signature Declaration
The vendor declaration letter required by 21 CFR §11.100(c) certifying that electronic signatures used in the system are intended to be the legally binding equivalent of handwritten signatures.
GAMP 5 Category 4 Classification
Formal classification document confirming the system as a configurable, commercially available software product — Category 4 under the GAMP 5 framework.
System Description & Intended Use
Scope statement, out-of-scope uses, intended user roles, and the regulatory context for which the system is intended — required for your PQ and IND/NDA packages.
Generated on demand · Always current
The VVP is not a static document. It is generated from live system state — test run ID, executed date, current version — so it never goes stale between your validation cycles.
21 CFR Part 11 — Clause by Clause
Compliance enforced at the architecture level, not configured on top. Every clause maps to a specific system control — not a policy you hope the software respects.
The system is validated per GAMP 5 Category 4. The VVP is generated on demand and reflects the current system version with live test evidence.
Every COA, CAPA, deviation, and audit log is exportable as PDF with a SHA-256 integrity hash verifiable independently.
Records are stored in isolated per-tenant databases with AES-256-GCM encryption at rest and TLS in transit. No shared storage layer.
Role-based access control with module-level gating. Training currency enforced — expired training hard-blocks access before the user can proceed.
5-year immutable audit trail on every action — user, IP, timestamp, resource. Tamper-evident, append-only, verified in every system test run.
Re-authentication required before every critical signature — COA issue, SOP sign-off, COC acceptance. Session state alone is not sufficient.
Incident Response Policy, Periodic System Validation Review Schedule, and Intended Use Statement available for download from the Compliance module.
Vendor declaration letter certifying electronic signatures are the legally binding equivalent of handwritten signatures — included in the VVP.
811 tests run monthly.
Results published in the platform.
The System Test Agent runs 811 end-to-end tests across 77 suites every month — covering authentication, audit trail immutability, COA integrity, 2FA, e-signatures, and negative-path security checks. Every run produces a timestamped report with pass/fail/warn per test case. This is your ongoing OQ evidence.
- COA SHA-256 hash re-verified on every test run
- Audit trail append-only enforcement probed automatically
- 2FA flows, token expiry, and account lockout exercised each run
- CLIA, SQF, and Pharma/GMP vertical compliance flows included
- Run ID, tenant ID, duration, and health score in every report
Latest system test
Health score · July 14, 2026
811
Tests passed
0
Failures
77
Suites
Full report available in Platform Admin → System Tests
Platform Reference
What's Actually Built
Live figures — source of truth: platformStats.js · last full run July 14, 2026
AI-NATIVE. · COMPLIANT BY DESIGN. · BUILT FOR TRUST.
Written Policies — §11.10(k)
21 CFR Part 11 requires written policies governing the use of electronic signatures and electronic records. These are available for download directly from the Compliance module.
Incident Response Policy
Detection, containment, investigation, tenant notification, and recovery procedures for security and data integrity incidents.
Periodic System Validation Review Schedule
Annual and trigger-based revalidation schedule covering access controls, audit trail, e-signatures, and change control per §11.10(a).
Intended Use Statement
System scope, GAMP 5 Category 4 classification, intended users, out-of-scope uses, and §11.100(a) vendor e-signature declaration.
Ready to hand your auditor
a complete validation binder?
The VVP is generated on-demand from your Compliance module. Book a demo and we'll walk through the full documentation package with you.
Also see: Security Architecture · Platform Overview · Pricing