Compliance
Compliance built in from the design
We build every solution to the standards a clinical research site demands.
21 CFR Part 11
Traceability and electronic signature
HIPAA compliant
Secure handling of patient data
Privacy by design
Security from the first sketch
21 CFR Part 11
We design workflows with electronic signature and traceability (audit trail): a record of who did what and when, integrity controls and versioning. We document the system to make audits easier.
HIPAA
When a solution handles patient data, we apply secure PHI handling: encryption in transit and at rest, role-based access control and business associate agreements (BAA) where applicable.
Privacy by design
We start from the principle of least privilege: we collect only the data needed, minimize its exposure and encrypt end to end. Security is decided in the first sketch, not at the end.
Documentation and support for audits
We deliver the technical and process documentation your quality team needs to respond to sponsors and auditors.
TODO: attach the compliance checklist and reference documentation when available.
Have an audit on the horizon?
We’ll help you get there with everything in order.