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Security and trust

Defensible, not aspirational.

What Deminn actually does today for Part 11 signatures, tenant isolation, authentication, and AI boundaries. No certifications we don't hold.

21 CFR Part 11, in code.

Part 11
  • §11.70

    Tamper-evident signatures

    Every signed approval includes a SHA-256 hash of the serialized record at signing time. Any subsequent edit detaches the signature from the snapshot and is visible in the audit trail.

  • §11.200

    Password reverification on every signature

    The caller is reauthenticated against their current password at the moment of signing - not the session. Failed password returns 401 without leaking whether record or credential was at fault.

  • §11.10(k)

    Append-only audit trail

    Approvals, revisions, and follow-through are written to an audit log in the same transaction as the signed record. Export as CSV at any time.

  • §11.10(d)

    Role-based approval chains

    Chains are defined per record type and enforced at the database layer. The signing user must hold the required role at the time of signature, not when the record was created.

Your data, your tenant, your visibility.

Data and tenancy
  • Per-org isolation

    Every record carries an organization ID. Every query, every API route, every background job filters by it. 119 database models, no cross-tenant leakage path.

  • Postgres with pgvector

    Managed Postgres for both structured records and semantic embeddings. Single database, single connection layer, no separate vector store to keep in sync.

  • Rate limiting at the edge

    Upstash Redis enforces per-user and per-org request budgets on write-heavy routes. Prevents brute force on the signature endpoint.

  • Observability scoped to your tenant

    LLM calls, tool invocations, and latency traced via Langfuse. Your prompts and outputs stay visible to you, not other organizations.

Clerk-backed auth. MFA today, SSO on pilot.

Authentication
  • Clerk-backed authentication

    Identity, sessions, and password policy managed by Clerk. No custom password hashing, no homegrown session tokens.

  • Multi-factor authentication

    TOTP and email verification supported today. Can be required at the organization level on pilot request.

  • SAML SSO

    Available on enterprise pilots. Talk to us during scoping; we configure per-org.

  • Session policy

    Idle timeout and forced reauthentication on sensitive actions, including every Part 11 signature.

Strict defaults. Verifiable in response headers.

Transport and HTTP
  • TLS 1.3

    In transit, everywhere.

  • HSTS preload

    max-age=2y · includeSubDomains · preload.

  • Strict CSP

    default-src self · no eval in prod · frame-ancestors none.

  • XFO DENY

    No embedding in third-party frames.

  • Referrer

    strict-origin-when-cross-origin.

  • Permissions

    Camera, microphone, geolocation disabled by default.

Your evidence does not train a third-party model.

AI boundaries
  • Your evidence does not train a third-party model.

    Model calls use provider APIs with training opt-out in effect. No fine-tuning on tenant data.

  • Providers are named, not hidden.

    Anthropic and OpenAI for reasoning. Voyage for embeddings. You see what leaves your tenant.

  • Prompts, outputs, and tool calls are traced.

    Every agent step is logged with the exact inputs, outputs, and token counts. Review any claim the system made.

  • No third-party data retention beyond the API call.

    Providers operate under zero-retention agreements where available; otherwise standard API retention applies. Posture stated explicitly during onboarding.

A straight answer beats a logo wall.

What we claim, what we don't

What we claim

  • 21 CFR Part 11 §11.70 and §11.200 are implemented in code (hashing, reverification).
  • Tenant isolation is enforced at the data layer across 119 models.
  • Every Part 11 signature, approval, and revision is recorded in an append-only audit log.
  • MFA is supported today via Clerk.

What we don't claim

  • SOC 2 Type 1 or Type 2 - not certified yet. On the roadmap.
  • HIPAA BAA - available on enterprise pilot, not a blanket default.
  • ISO 27001 - not certified.
  • FDA or notified body "validation" - you validate for your organization. Deminn provides the evidence and controls.
  • Data residency beyond the primary hosting region - ask for specifics per pilot.

Pressure-test the trust model on a real CAPA.

Bring one representative (or sanitized historical) CAPA. Judge the signatures, audit trail, and boundaries for yourself. We answer security questions in writing.