01URS
Equipment User Requirements Template
Requirements, rationale, risk, verification method, acceptance criteria, and traceability
DOCUMENT PACK
Five validation documents from requirements through approval
Editable DOCX drafts with document control, traceability, execution records, and review and approval fields.
Documents are a starting point.
Revise them for the actual product specification, risks, regulatory and quality scope, and approval responsibilities before use. The downloadable drafts are currently provided in Korean.
Download DOCX
02USE
Usability Validation Template
Users, environments, critical tasks, scenarios, observations, use errors, and conclusions
03IQ
Installation Qualification Template
Installation environment, components, documentation, utilities, calibration, and safety
04OQ
Operational Qualification Template
Operating ranges, alarms, interlocks, worst-case conditions, and test results
05PQ
Performance Qualification Template
Actual conditions, repeats, lots, operators, performance metrics, and disposition
DOCUMENT CONTROL
Distinguish drafts from approved records.
These downloads are public drafts. They do not represent Trova Health approval, certification, or a validation conclusion.