21 CFR §11.10(e)
Append-only audit log + Postgres trigger. Records cannot be altered or obscured. Shipping today.
Pharma & Life Sciences
21 CFR Part 11 e-records, on the platform you can already audit.
The infrastructure regulated industries demand - DB-trigger immutability, cryptographic action chain, per-tenant CMK - is shipping today. The Pharma corpus and GxP-specific rules are next.
Roadmap
Architecture-first
The substrate is pharma-grade today.
The hardest parts of regulated-industry compliance - immutable e-records, signed action chains, MFA-enforced authentication, per-tenant encryption - already ship. We're not retrofitting them onto a generic SaaS; they're foundational.
What we don't ship today is the corpus. 21 CFR Part 11, EU GMP Annex 11, USP <1058> - those are licensed. We're partnering with 2-3 pharma compliance leads to define the rule set, validate it, and ship a Pharma-ready release in Q3 2026.
§11.50 / §11.70
HMAC-signed action chain. Tampering breaks chain validation; the system flags it at audit time.
§11.300 unique IDs
Magic-link + JWT + TOTP MFA. Owner-role MFA enforced on Enterprise.
Per-tenant CMK
Customer-managed encryption keys. Sovereign tier pins to your region of choice.
7yr
Audit retention
KMS
Per-tenant key
What our architecture already gives you
These are not roadmap claims - these are shipped today and are the substrate every Pharma feature will sit on.
Append-only audit log + Postgres trigger
21 CFR §11.10(e) demands records cannot be obscured or altered. Our log raises a database error on UPDATE/DELETE - even compromised admins cannot rewrite history.
HMAC-signed action chain
§11.50 / §11.70 - every workflow action is HMAC-chained. Tampering with one row breaks chain validation; the system flags the breach at audit time.
Magic-link auth + TOTP MFA
§11.300 - unique user identification with two distinct components. Owner role MFA-enforced on Enterprise tier.
Per-tenant CMK on Enterprise
Customer-managed encryption keys for tenants under PHI / regulated workloads. Sovereign tier pins to a region of your choice.
Time-stamped electronic signature primitive
Workflows store signer identity, role, timestamp, IP, and a chained HMAC. All the inputs §11.50 requires - minus the rendering layer for biometric / handwritten capture.
GxP / cGMP rulebook RAG
The same RAG pipeline that validates SQF and BRCGS today, pointed at your licensed 21 CFR Part 211 / EU GMP Annex 11 corpus. Q3 2026 design-partner build.
Multi-tenant isolation, demonstrated
Pharma data demands strict isolation. Pick a tenant context, fire a query, watch the row-level-security policy decide. Even running with no tenant scope returns zero rows - RLS fails closed.
App server
app.tenant_id = A
Postgres
RLS policyawaiting query
?
Run a query to see the result
-- middleware injects this per request SET LOCAL app.tenant_id = 'a1111111-…-aaaa'; -- application code (no manual filtering) SELECT * FROM documents; -- Postgres applies this RLS policy: USING (tenant_id = current_setting('app.tenant_id')::uuid) WITH CHECK (tenant_id = current_setting('app.tenant_id')::uuid);
What just happened: Pick a tenant context above and run the query. The same SQL behaves differently per session because the RLS policy reads app.tenant_id.
How we get to Pharma-ready
Dates are targets, not commitments. Design partners get earlier access.
Q2 2026 - Foundation
- Pharma-specific document types (BMR, batch record, deviation report)
- Pre-built templates for batch release
- cGMP audit log retention windows (7-year minimum)
- Validated environment / IQ-OQ-PQ artifacts
Q3 2026 - Validation
- Licensed corpus ingest (21 CFR Part 211, EU GMP Annex 11)
- rag_check rules per critical clause
- Biometric / handwritten signature capture
- Design-partner pilot with 2 clients
Q4 2026 - GA
- Computer System Validation pack
- Annex 11 self-assessment matrix
- BAA + HIPAA region pinning (US-East / EU-Central)
- Validation services partner network
Be a Pharma design partner.
We need 2–3 Pharma compliance leads to define the corpus and validate clause-level rules. Earlier access, lower pricing, and direct input into the validation framework.