GAMP 5 Validation Package (Preview)
Category 4 · configurable off-the-shelf · draft for design partners · signed release with the 21 CFR Part 11 GA (2027-Q2).
1. Scope & GAMP 5 categorisation
formulize.dev is classified as GAMP 5 Category 4 — Configurable software. The symbolic-regression engine ships fixed; per-tenant configuration is limited to (a) input schemas, (b) fitness / regularisation weights, (c) allowed operator set, (d) rate + concurrency limits. All configuration is version-controlled and reversible.
Intended-use statement covers: exploratory PK/PD modelling, dose-response fitting on published or simulated data, and hypothesis-generation for candidate mechanistic equations. Not qualified for pivotal (GLP/GCP) submissions until Part 11 GA.
2. Deliverables checklist
| Artifact | Status | Where |
|---|---|---|
| Vendor qualification questionnaire (VQQ) response | Available | Email [email protected] — 24h turnaround |
| SBOM (Software Bill of Materials) | Available | SPDX 2.3, generated per release, delivered with each Enterprise deploy |
| SOP · Model qualification workflow | Draft | v0.7 draft; under review by external QA consultant; final 2026-11 |
| IQ (Installation Qualification) scripts | Draft | Available as executable Python; deterministic-install verifier for Enterprise self-host |
| OQ (Operational Qualification) scripts | Draft | End-to-end fit-→-predict-→-rollback smoke tests on 12 canonical Nguyen problems, seed-pinned |
| PQ (Performance Qualification) scripts | 2026-Q4 | Customer-supplied dataset harness; template ships with pharma-tier |
| Requirements traceability matrix (RTM) | Draft | Excel + generated diff on release; ties each user requirement to a test case + code commit |
| Change control SOP | Draft | Aligns with our /v1 API 12-month deprecation policy; Enterprise gets 30-day pre-release notification |
| Audit trail (21 CFR Part 11 §11.10(e)) | 2027-Q2 | Immutable append-only log per tenant; export in Ed25519-signed JSONL |
| Electronic signatures (§11.100–11.300) | 2027-Q2 | Biometric + credential-based e-sig via WebAuthn; ties to model runs, not just files |
| Data integrity — ALCOA+ compliance statement | Draft | Covers attributable / legible / contemporaneous / original / accurate + complete / consistent / enduring / available. Under external review. |
| Retirement SOP | 2027-Q1 | Model-version retirement + tenant-data-export workflow |
3. Reproducibility & determinism
- Deterministic search: RNG seed defaults to
42, honored across search, bootstrap, and CV split. Two fits with same input + same seed produce byte-identical output. - Compute-determinism claim: Numerically identical results across CUDA 12.x on Ampere/Ada. Cross-architecture determinism (e.g., Hopper H100 vs 4090) requires
--strict-determinismflag; adds ~15% wall-time. - Residuals: every fit response includes a
residuals_urlto a signed CSV (24h expiry), retrievable for full audit trail. - Model versioning:
/v1/deploy/{id}/versionsreturns full version history with commit SHA, deployed_at, and equation form.
4. Design-partner program (pharma tier, pre-GA)
Three pharma design-partner slots are open for the pharma tier (pre-Part 11 GA). Design partners get:
- Access to draft SOP + IQ/OQ scripts under NDA (today)
- Named QA-liaison at formulize.dev
- Input into the Part 11 audit-trail schema before it locks
- 50% discount on pharma-tier pricing for 24 months post-GA
- Right of first review on the signed GAMP 5 package at GA
Design partners commit to: (a) at least one internal (non-IND) pilot on the platform, (b) written feedback on the validation package at 3 checkpoints, (c) reference-call availability for two future pharma prospects.