AI Registry™
Inventory AI systems, models, applications, agents, vendors, owners, status, and business context.
SMART RISK 2IN ACTIVE DEVELOPMENT
Operational AI governance that can show its work.
Create a living governance record for every AI system—connecting context, risk, human authorization, controls, validation, evidence, remediation, and monitoring.
AUTHORIZATION DECISIONCONDITIONAL
AI system
Clinical deterioration model
Production use · High impact · Human decision support
RiskHIGH
Controls12 / 14
ValidationPASS*
Evidence91%
!
Authorization conditionComplete subgroup performance review before expanded deployment.
Human approval requiredQUALITY · CLINICAL · AI GOVERNANCE
Contextual
Controls reflect the system’s purpose, impact, users, and regulated environment.
Evidence-based
Assessments remain connected to validation, artifacts, rationale, and approvals.
Continuous
Material change and operational signals can trigger renewed governance action.
The SR2 capability system
Seven connected modules. One governance record.
SR2 is being developed as a modular platform. The architecture below represents intended capability; availability will be confirmed as modules reach pilot and production readiness.
AI Profile™
Capture intended use, users, affected people, data, autonomy, decision impact, and deployment context.
Risk Engine™
Apply repeatable risk logic while preserving the context that makes each system different.
Validation™
Connect requirements, test plans, results, exceptions, conclusions, and approval.
Governance Remediation™
Turn missing controls and evidence into assigned, time-bound corrective work.
Evidence Vault™
Maintain the artifacts and decision history needed to explain and defend governance outcomes.
Continuous Monitoring™
Use performance, change, incident, and control signals to initiate reassessment.
The Governance Case™
A defensible case for authorizing—and continuing to operate—AI.
Instead of scattering governance across tickets, spreadsheets, policies, and meeting notes, SR2 is designed to preserve the complete reasoning chain.
Purpose
What the AI does, where it operates, and who it can affect.
Risk
What can go wrong, how serious it is, and who owns it.
Controls
What safeguards, oversight, and limits are required.
Evidence
What demonstrates that requirements and controls are satisfied.
Decision
Who authorized use, under which conditions, and why.
Assurance
What must be monitored and what triggers intervention.
Designed for regulated depth
Enterprise governance connected to real product evidence.
This is the planned SmartRisk distinction: broad AI oversight anchored in the risks, quality controls, validation, and lifecycle records that regulated teams already manage.
Enterprise governance
Portfolio visibility, policies, ownership, risk tiers, approvals, and executive reporting.
Regulated-use governance
Domain-specific controls and evidence for medical devices, life sciences, and healthcare.
Product-risk evidence
Detailed hazards, failure modes, controls, validation, and residual risk connected from SR1.
Initial specialization
Medical Device AI Governance™
The first vertical focus connects enterprise AI governance to medical-device risk management, design controls, validation, change control, human oversight, postmarket monitoring, CAPA, and regulatory evidence.
01AI-enabled product profile
02ISO 14971 traceability
03Validation assurance
04Human authorization
05Regulated change assessment
06Postmarket & CAPA connection
Expansion path: Pharmaceutical & Biotech AI Governance™, Clinical Research AI Governance™, and Healthcare Delivery AI Governance™ will require dedicated domain packs built on SR2 Core.
PRODUCT TRANSPARENCY
Built ambitiously. Presented honestly.
SR2 is in active development. The AI Registry, AI Profile, Risk Engine, governance, validation, evidence, remediation, and monitoring capabilities will mature in stages. Demonstrations and proposals will identify which functions are available, piloting, or planned.
AvailableReady for demonstrated use
PilotControlled validation with design partners
PlannedApproved product direction
Help shape the operating layer
Build governance that accelerates trusted AI adoption.
Discuss your governance model, regulated use case, or interest in becoming an SR2 design partner.