BioCompute at a Glance
BioCompute is the life sciences product in the iTmethods Fortress Family — alongside Reign (AI governance) and Forge (DevOps). The same governance architecture your enterprise trusts, purpose-built for FDA 21 CFR Part 11 and life sciences regulatory requirements.
- AI Gateway — MCP-native gateway, PHI/PII redaction, agent tool-call governance, model routing across 100+ LLMs
- Model Lifecycle — approved-model registry, FDA PCCP-aligned change packets, drift detection
- Evidence Engine — immutable audit trails, e-signatures, cryptographic integrity
- Regulator Packs — submission-ready packages for IND, NDA, BLA, PCCP, 510(k), DORA, AIGF, ISO 42001
- Four deployment tiers from SaaS to Air-Gapped — every tier managed with Forward Deployed Engineers
Pharmaceutical companies, biotech firms, CROs, CDMOs, and diagnostics companies who need sovereign AI without compromising data sovereignty or regulatory compliance.
SaaS · Dedicated (BYOK) · Customer Cloud (your VPC) · Air-Gapped — every tier managed with FDEs
21 CFR Part 11, GxP, HIPAA, SOC 2, EU AI Act, ISO 42001, NIST AI RMF
90-Day Proof of Value (custom-scoped). Dedicated FDE with every deployment.
Your AI works in the lab. Can it survive an FDA audit?
Compliance-native. Validation-ready. Lab to production.
Most life-sciences AI is built on consumer cloud, internal notebooks, and ad-hoc tooling — none of it built to satisfy 21 CFR Part 11, ALCOA+, FDA PCCP, or EU AI Act Art. 10. When the asset moves from research to clinical or commercial, the evidence chain breaks.
BioCompute is the AI Governance Platform for Life Sciences — same four-component architecture as Reign, with life-sciences-specific extensions: clinical PHI redaction, GxP-aware MCP tooling, PCCP-aligned change control, ALCOA+ data integrity, and IND/NDA/BLA/PCCP/510(k) submission packaging on demand.
Deployment
Same governance layer across every tier.
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. Compliance-native. Validation-ready. Lab to production.
Platform Summary
Full-Stack AI Governance for Life Sciences
Five integrated products governing every layer of the AI threat surface.
AI Gateway
MCP-native gateway. Prompt guardrails, PHI/PII redaction, agent tool-call governance, model routing across 100+ LLMs
Model Lifecycle
Approved-model registry, version control, FDA PCCP-aligned change packets, drift detection
Evidence Engine
Immutable audit trails, e-signatures, cryptographic integrity
Regulator Packs
Submission-ready packages for FDA, EU AI Act, GxP, HIPAA, ISO 42001, NIST
Expand from Reign
Already Using Reign?
BioCompute extends your AI governance with 21 CFR Part 11 compliance, life sciences-specific Regulator Packs, and domain AI modules — on the same platform your enterprise already trusts.
Same Platform
Built on the Reign governance engine
+ Life Sciences
21 CFR Part 11, GxP, FDA compliance
+ Domain AI
Bio Intelligence modules for discovery
The Fortress Family
Three Products. One Governance Architecture.
The same Evidence Engine, AI Gateway, and FDE model — specialized for your industry and use case.
Continue to
Three lenses on BioCompute.
The Promise
Lab to regulated production. On one platform.
Five promises BioCompute commits to across every product, every deployment, every customer engagement.
Read the promiseNative Components
Four components. One platform. Built for life sciences.
Same four-component architecture as Reign, extended for life-sciences specificity. Compliance-native, validation-ready.
Explore componentsDeployment & Defensibility
Built for every deployment. Built to defend.
Four deployment modes, native intoDNA STRIDE® specialty, and a four-part moat designed to compound.
See the moatExplore the Full BioCompute Platform
Interactive architecture, deployment details, comparison matrix, Learn Hub, Design Partner Program, and demo — all on biocompute.ai.
Frequently Asked
How does BioCompute relate to Reign and Forge?
Reign governs AI policy and generates evidence for compliance frameworks across the enterprise. Forge delivers the managed runtime that engineering teams build on. BioCompute extends both with life-sciences-specific layers — sovereign data, GxP workflows, and domain AI — purpose-built for R&D, clinical, and manufacturing workflows.
What deployment options are available?
Four tiers: SaaS, Dedicated (BYOK), Customer Cloud (your VPC), and Air-Gapped. Every tier includes a dedicated Forward Deployed Engineer (FDE). Full details at biocompute.ai.
Can I use BioCompute if I already use Reign?
Yes — BioCompute extends your existing Reign governance with 21 CFR Part 11 compliance, life sciences-specific Regulator Packs, and domain AI modules. The same platform your enterprise already trusts, with life sciences regulatory requirements built in.
How do I get started?
Start with a 90-Day Proof of Value (custom-scoped) — validate with your own data and workflows. Every engagement includes a dedicated Forward Deployed Engineer. Visit biocompute.ai for full details.