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. Full platform details at biocompute.ai.
- AI Gateway — prompt guardrails, PII redaction, model routing across 100+ LLMs
- Agentic Hub — MCP governance, tool verification, agent chain tracing
- Evidence Engine — immutable audit trails, e-signatures, cryptographic integrity
- Evidence Books — submission-ready packages for 6 regulatory frameworks
- 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 at $25K. Dedicated FDE with every deployment.
Platform Summary
Full-Stack AI Governance for Life Sciences
Five integrated products governing every layer of the AI threat surface.
AI Gateway
Prompt guardrails, PII redaction, model routing across 100+ LLMs
Agentic Hub
MCP governance, tool verification, agent chain tracing
Evidence Engine
Immutable audit trails, e-signatures, cryptographic integrity
Evidence Books
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 Evidence Books, 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.
Explore 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 modern DevOps platform 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 Evidence Books, 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 at $25K — validate with your own data and workflows. Every engagement includes a dedicated Forward Deployed Engineer. Visit biocompute.ai for full details.