AI is now a Part 11 risk you have to evidence.
Tokto gives the life-sciences risk and compliance officer one record that ties every prompt, every model output, and every CRO-shared AI use to a program, a trial, and a submission, ready for the FDA, the EMA, OCR, the IRB, and the board risk committee.
An AI-assisted submission stalls at the FDA over reproducibility. OCR opens a HIPAA inquiry after a vendor breach. The board risk committee asks the CRO for AI exposure across R&D, clinical, and regulatory. Industry data says most peers have no basic AI controls, and the risk function cannot prove this company is different.
What you get with Tokto
- Every AI interaction scored and recorded against a program, a trial, a site, a model version, and a data classification.
- A Part 11-grade evidence layer the FDA, the EMA, OCR, the IRB, and the board risk committee read against the same record.
- Policy enforced at the prompt: PHI blocked, compound and trial codenames redacted, CRO boundaries enforced before tokens leave the company.
- AI risk that is measured by function, controlled at the prompt, and attestable to the board and the auditor.
How it works
Tokto turns AI across the pipeline into a managed, evidenced control. Every research co-pilot, every regulatory drafting tool, every CRO-shared model becomes a scored record at the moment of output, tied to the molecule, the trial, the data classification, and the policy in force. The risk function gets the AI control layer GxP and Part 11 already assume.
When the FDA asks for the AI history behind a Part 11 record, when OCR opens a HIPAA inquiry, when the IRB asks how patient data was governed, the answer is one query against the system of record. The CRO reports AI risk alongside quality and patient-safety risk, with a control and a trail.
What goes wrong without it
- AI risk is never controlled. Industry research says 83% of peers have no basic controls — and this company is one of them.
- A scientist pastes compound IP into a public model. The exposure is found after the molecule has left the boundary.
- A CRO co-pilot retains trial data past the contract. The register never flagged it.
- An AI-assisted submission cannot be reproduced. The FDA opens an integrity review.
On January 6, 2025, HHS OCR proposed the first major HIPAA Security Rule update in 20 years, removing the distinction between required and addressable safeguards and tightening risk management and resilience expectations. In May 2025 the Serviceaide breach exposed PHI for 483,126 Catholic Health patients through an unsecured database. Industry research finds 83% of pharma organizations operate without basic technical controls preventing molecular structures, trial data, and PHI from leaking into public AI tools.
See how Tokto makes enterprise AI visible, governed, and accountable for Regulatory / Risk in Life Sciences.
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