Six components. One platform. Built for life sciences.
Six native components, integrated by design — purpose-built for regulated pharma, biotech, clinical diagnostics, and academic research. The same six components that power Reign, extended for life-sciences specificity. Compliance-native, validation-ready, lab to production.
The Problem
One platform with a broken chain isn't a platform.
Life-sciences AI requires governance across the full lifecycle — from data ingestion through model selection, runtime enforcement, evidence capture, and regulatory submission. Most platforms cover one or two stages and force the customer to integrate the rest. The integration is the hard part — and it is where audit chains break, evidence gets lost, and submissions fail.
- 1
Generic AI platforms (foundation-model providers, hyperscaler AI) cover model serving but not governance, audit, or submission packaging.
- 2
Compliance tools (audit-trail systems, validation suites) cover one regulatory framework but not AI runtime or model lifecycle.
- 3
MLOps platforms (MLflow, Vertex AI, SageMaker) cover model development but not regulatory mapping or evidence assembly.
- 4
Running these as separate tools loses the chain of custody — regulators evaluate end-to-end, and gaps invalidate the submission.
- 5
Six components, one platform, one chain — is the architecture regulated life sciences actually requires.
The Six Native Components
Six components. Each compliance-native.
Each component is purpose-built for life sciences. Each maps to specific regulatory citations. All six are integrated by design.
AI Gateway.
Decide what AI is allowed to do. Model access control, clinical PHI/PII redaction, foundation-model and biomedical-model routing, cost governance.
Data Vault.
Where life-sciences data lives. Patient data residency, BYOK encryption, lineage, validated retention. Sovereign by design across every deployment tier.
Agentic Hub.
Governed access to the regulated AI toolchain. Every MCP tool call governed across PubMed, ClinicalTrials.gov, Medidata, 10x Genomics, LIMS, statistical packages, and the rest of the regulated stack.
Model Lifecycle.
Validated. Versioned. Change-controlled. Drift-detected. Mapped to FDA PCCP, EU AI Act Article 15, and ISO 42001 §9.1 from the architecture up.
Evidence Engine.
Real-time and retrospective capture of every prompt, tool call, model version, and output. 21 CFR Part 11 native. ALCOA+ aligned.
Evidence Packs.
Submission-ready regulatory artifacts assembled from the continuous evidence chain. IND, NDA, BLA, PCCP, 510(k), DORA reports, AIGF assurance.
How the six components integrate
The integration is the moat.
Each component feeds the others. AI Gateway enforces what Model Lifecycle authorizes. Data Vault lineage flows into Evidence Engine. Model Lifecycle change packets flow into Evidence Engine. Evidence Engine feeds Evidence Packs. Agentic Hub coordinates with Data Vault and AI Gateway on every tool call. The end-to-end audit chain — from raw data through model decision to regulator-ready submission — is unbroken because the components are designed to integrate. Competitors offering one or two of these in isolation cannot deliver the same chain of custody.
BioCompute and Reign
Same six. Different scope.
Reign provides the same six native components for general enterprise AI governance — financial services, regulated technology, defense, capital markets. BioCompute extends them for life-sciences specificity: ALCOA+ data-integrity by default, FDA PCCP-aligned change control, 21 CFR Part 11 native evidence capture, GxP envelope mapping, IND/NDA/BLA submission packaging, and native specialty integrations like intoDNA STRIDE®. Customers operating across both general enterprise AI and life-sciences AI get one architecture, one audit model — Reign and BioCompute together.
General-enterprise scope of AI Gateway — Reign's view of the same component.
General-enterprise scope of Data Vault — Reign's view of the same component.
General-enterprise scope of Agentic Hub — Reign's view of the same component.
General-enterprise scope of Model Lifecycle — Reign's view of the same component.
General-enterprise scope of Evidence Engine — Reign's view of the same component.
General-enterprise scope of Evidence Packs — Reign's view of the same component.
Compliance and framework mapping by component
Each component, mapped to its regulators.
AI Gateway
EU AI Act Art. 14 (human oversight); HIPAA access controls; FDA GMLP Principles 1, 7.
Data Vault
HIPAA; GDPR; PHIPA / PIPEDA; EU AI Act Art. 10; ISO 27001; 21 CFR Part 11; ALCOA+ data integrity.
Agentic Hub
EU AI Act Art. 15 (cybersecurity); FDA GMLP Principle 8; FINOS AIGF (when paired with Reign).
Model Lifecycle
FDA PCCP; EU AI Act Art. 9, 15; ISO 42001 §9.1; FDA GMLP Principles 9, 10.
Evidence Engine
21 CFR Part 11; ALCOA+; ICH Q9; EU AI Act Art. 12; ISO 42001 §10.
Evidence Packs
FDA IND / NDA / BLA / 510(k); FDA PCCP submission templates; EU AI Act Art. 11; DORA reporting; AIGF assurance reports.
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.