Security and compliance
Security and compliance, stated plainly
What Protocol AI does today, what is planned and what we do not claim.
Built in today
Early access
Audit trail
Every change records who made it, when and why.
Early access
Role-based access
People see and change only what their role allows.
Early access
Human approval
AI output is a draft. Nothing enters the plan without a named reviewer.
What we do and do not claim
- Protocol AI is designed to support 21 CFR Part 11 controls. We do not claim validated or Part 11 compliant status. Before regulated use, validation and controls are assessed and agreed with you for your intended use.
- The approval history is meant to support the sponsor oversight described in ICH E6(R3). Your procedures still matter.
- Do not upload identifiable participant information during early access. Any future handling of health information needs the right agreements, including a BAA where required, and verified security controls first.
- We do not claim SOC 2, ISO 27001 or HIPAA certification. If your review needs a security questionnaire, ask us and we will answer it in writing.
Have a security or quality question?
Bring your checklist to a 30-minute call. We answer in plain language and follow up in writing.
Prefer email? Write to jmodi@manakiki.net. A person replies, usually within one business day.