What a security review will find
Answered here rather than in a questionnaire, because you were going to ask anyway.
Customer data is protected by administrative, technical, and physical safeguards, including access controls, audit logging, and encryption of data in transit and at rest.
Part 11-capable controls: audit trail, e-signature, access control
The FDA runs no certification program for Part 11 software — compliance attaches to the operating organization, not to a vendor’s product. What quako ships is that set of controls, built to support your compliance. Qualifying them against your intended use, and writing the SOPs around them, stays with you.
Validation evidence is shared, not outsourced
Installation and operational qualification scripts, requirements traceability, and release evidence are available to support your computer system validation. Executing them in your environment, and the performance qualification against your intended use, remain yours to own.
SOC 2 Type II report available under NDA
Ask for the current report when you get in touch.
PHI is contractually prohibited on this platform
quako is scoped to quality-system records — device history, CAPA, training, supplier data — not patient health information.
Data Processing Addendum Sub-processors Privacy Policy security.txt