Architecture overview
Built like the audit trail depends on it.
Because it does.
The public-safe version of what our engineers run. For the full picture, request the Validation Accelerator Package under NDA.
The shape of the system
Five layers, trust at the bottom; one five-pillar runtime shared by all fifteen modules.
The facts a reviewer asks for first
Application
Modern TypeScript stack: React/Next.js front end, Node.js services, document database with vector search, S3-compatible evidence storage.
Multi-tenancy
Logical isolation with tenant scoping enforced at four layers — route middleware, service guards, query helpers, and cross-tenant CI tests that block release on regression. Dedicated database + BYOK available on Enterprise.
AI layer
A single in-house gateway is the only path to any model provider (Anthropic, OpenAI, Google, local path). Grounded retrieval over your evidence + the curated regulatory corpus; PII redaction pre-flight; per-tenant provider preferences.
Records & evidence
Versioned documents, SHA-256 record hashing, append-only audit trail with reason-for-change on every state transition. Signatures bind to a snapshot hash of the signed record.
Residency & lifecycle
Region elected at provisioning (India, US, EU); data never leaves the elected region without explicit instruction. Full export within 7 business days; deletion with signed certificate within 30 days.
Deployment
Cloud multi-tenant SaaS today. A validation-gated sovereign/on-prem option (customer infrastructure, local model serving) is in design with partners — roadmap, not GA.
GAMP 5 Category 4 configured product · configuration, not code forks, per tenant · every AI call audit-trailed with model version, prompt hash and retrieval set.
CTO questions welcome.
Architecture walkthrough with the people who built it — not a sales engineer reading slides.