Lab to regulated production. On one platform.
BioCompute is the dedicated life-sciences company within iTmethods' AI Governance family, founded by the same team behind iTmethods and Reign. We are building the AI governance platform purpose-built to take pharma, biotech, clinical diagnostics, and academic research AI from research notebooks to regulator-defensible production — on one platform, one governance layer, one audit chain.
Part of the iTmethods AI Governance Family
BioCompute is the dedicated life-sciences company within iTmethods' AI Governance family — founded by the same team behind iTmethods and Reign.
The Problem
Research velocity. Regulator-grade evidence. Most platforms force a choice.
AI in regulated life sciences faces a chasm between research and production. Research velocity is high but unauditable. Production is auditable but slow. The two systems do not talk to each other, and regulators evaluate the entire chain end-to-end. Compressed timelines are making the gap impossible to close manually.
- 1
Research-stage AI runs on consumer cloud, internal notebooks, and ad-hoc tooling — none of it built to satisfy 21 CFR Part 11, ALCOA+, or FDA PCCP.
- 2
Production-grade AI requires validation, change-control, evidence capture, and regulatory packaging that research teams typically rebuild from scratch when an asset moves from discovery to clinical or commercial.
- 3
The CMS-FDA RAPID coverage pathway (announced April 2026) compresses Medicare coverage from 12 months to roughly 60 days — making retrospective evidence assembly impossible.
- 4
EU AI Act enforcement begins August 2026; FDA PCCP guidance is live; ISO 42001 in active deployment. Three regulatory windows are opening simultaneously, and they all expect continuous evidence.
- 5
Multinational pharma needs to defend AI use in front of FDA, EMA, COFEPRIS, Health Canada, and PMDA — under different framework expectations, from one underlying audit chain.
The Five Promises
Five things. Always.
BioCompute commits to five things. Always. Across every product, every deployment, every customer engagement.
Compliance by construction.
Every capability maps to a regulatory citation. Designed in, not retrofitted.
Sovereignty by default.
Customer data, IP, and models never leave customer control. Same governance from SaaS to air-gapped.
Models you can defend.
Validated, versioned, change-controlled, and drift-detected — for FDA PCCP, EU AI Act, and ISO 42001.
Audit-grade, always.
Every prompt, tool call, model version, and output captured to 21 CFR Part 11 standard.
Submission-ready on demand.
The audit chain drops directly into IND, NDA, BLA, PCCP, and 510(k) filings — on demand.
How it fits in the Fortress Family
Forge owns runtime. Reign owns risk. BioCompute owns regulation.
BioCompute extends the iTmethods AI Governance family into regulated life sciences. Built on Forge's sovereign managed runtime; the Reign governance core extends naturally into BioCompute, with life-sciences-specific extensions on top. Native intoDNA STRIDE® integration on day one. NVIDIA Inception Partner. Every engagement includes a Forward Deployed Engineer who embeds with the customer team and owns outcomes.
Reign
Owns risk — enterprise AI governance.
Forge
Owns runtime — sovereign managed infrastructure.
BioCompute
Owns regulation — life sciences AI governance.
Compliance and framework mapping
Mapped to the regulators evaluating you.
21 CFR Part 11
Electronic records, audit trail, electronic signatures.
ALCOA+
Data integrity attributes — Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available.
FDA PCCP
Predetermined Change Control Plan for AI/ML-enabled SaMD.
EU AI Act
Articles 9, 10, 11, 12, 14, 15 — risk management, data governance, technical documentation, record-keeping, human oversight, lifecycle accuracy.
CMS-FDA RAPID
Compressed Medicare coverage pathway (announced April 2026); requires continuous evidence.
HIPAA / GDPR / PHIPA / PIPEDA
Patient data privacy across North American and European jurisdictions.
GxP envelope
Good Clinical, Manufacturing, and Laboratory Practice.
ICH Q9 / Q10
Pharmaceutical quality risk management and quality systems.
ISO 42001
AI Management System.
FDA GMLP
Good Machine Learning Practice — ten guiding principles.
FAQ
Frequently asked
Continue exploring BioCompute
One platform. Three lenses.
Promise
Lab to regulated production. On one platform.
Components
Six components. One platform. Built for life sciences.
Deployment & Defensibility
Built for every deployment. Built to defend.