GCLP Audit Checklist for Clinical Laboratories

This GCLP audit checklist helps clinical laboratories assess compliance with Good Clinical Laboratory Practice. It guides auditors through organization and personnel, training and competency, SOP governance and change control, inspections and certifications such as CLIA and CAP, facility security and environmental controls, equipment qualification and maintenance, laboratory controls and validations, reagent labeling and inventories, sample receipt, shipment and storage, data handling and 21 CFR Part 11 compliance, documentation, reporting, and archival. Capture findings and define CAPA to drive continuous quality improvement.