AI innovation for regulated environments, without losing control, compliance, or audit readiness.
Full validation and CSA services for organizations where AI mistakes carry real regulatory consequences.
Who it's for
Life sciences, healthcare, medical device, biotech, pharma, financial services, government contractors, and regulated manufacturing.
The problem
Regulated organizations can't adopt AI the way a startup does: every model, vendor, and workflow needs a defensible validation trail before it can touch a real process, and most AI vendors have no idea what that means.
The process
Timeline: Scoped per engagement
Risk & Intended Use
Define exactly what the system is intended to do and assess the risk of it doing so.
Validation Strategy
A CSA-aligned validation and test strategy built around your specific regulatory context.
Execution & Verification
Test execution with full requirements traceability and model output verification.
Audit Readiness
A complete audit-ready package: SOPs, change control, and documentation your regulators expect.
Deliverables
- AI risk assessment
- CSA validation strategy
- Intended use definition
- Requirements traceability
- Vendor assessment
- Test strategy
- Output verification plan
- Change control
- Audit readiness package