Compliance at Keiji AI

Compliance

Keiji AI's certifications, audits, and qualifications, with reports shared under a non-disclosure agreement (NDA).

ISO/IEC 27001:2022SOC 2 Type 1 & Type 2HIPAAGxP

Certifications, audits, and qualifications

Certificates and audit reports are shared with customers and prospects on request under NDA, as their own terms require.

ISO/IEC 27001:2022: Certified. International standard for an information security management system (ISMS). Issued February 2026 by Accorp Partners. Covers the infrastructure, applications, and systems delivering the Keiji AI platform.Request under NDA
SOC 2 Type 2: Audited. Service Organization Control 2 (SOC 2) audit of operating effectiveness against the Security, Availability, and Confidentiality Trust Service Criteria for the TrialMind application, covering 14 February 2025 to 13 February 2026. Next audit window runs to 13 February 2027.Request under NDA
SOC 2 Type 1: Audited. SOC 2 audit of the design of security, availability, and confidentiality controls at a point in time.Request under NDA
HIPAA: Readiness assessed. Continuous control monitoring against the Health Insurance Portability and Accountability Act (HIPAA) Security Rule safeguards, independently assessed. HIPAA has no certifying body, so this is a readiness report rather than a certificate.Request under NDA
GxP: Qualified. GxP refers to good practice regulations such as good clinical practice. Qualified September 2026: Data Science Assistant v1.0.0 qualified as a GxP computerized system under the GAMP 5 (Good Automated Manufacturing Practice) risk-based approach, with electronic-records controls for 21 CFR Part 11 (FDA rules for electronic records and signatures) and EU Annex 11 (European rules for computerized systems). All 87 user requirements traced to passing tests run by independent testers; Qualification Summary Report available under NDA.Request under NDA

Platform security

Hosted on Amazon Web Services (AWS), with an information security management system certified to ISO 27001 and audited under SOC 2 Type I and Type II.

Cloud infrastructure

Hosted on Amazon Web Services (AWS)

Access control

Access controls that limit data to authorized users

Data ownership

Customers keep full ownership and control of their data; the platform works with any data source

Compliance support

Built to support HIPAA and other regulatory frameworks

Privacy and compliance

Customer data ownership

Keiji AI works with data from any source, and customers keep ownership and control of their data.

Support for customer compliance

Access control and data management help you meet HIPAA and other privacy regulations and industry standards.

Audits and ongoing improvement

Independent audits, certifications, and ongoing improvements to security controls protect data on the platform.