IQ/OQ Documentation for Laboratory Equipment (CLIA Compliance)

Looking for an experienced professional to complete Installation Qualification (IQ) and Operational Qualification (OQ) documentation for two lab instruments using existing calibration and test data. The work includes document review, gap assessment, preparation of IQ/OQ protocols and reports, and organizing all records into a CLIA-ready audit package. Must be completed remotely within a strict timeline.

Scope of Work:

Review provided calibration, verification, and test documents

Perform gap assessment

Prepare IQ documentation (installation, configuration, checklist)

Prepare OQ documentation (protocol, acceptance criteria, report)

Map existing data to OQ requirements (traceability)

Compile all service and calibration records into one package

Deliver complete audit-ready IQ/OQ documentation


Timeline:

Must be completed within 4 business days