GCLP Audit Checklist for Clinical Laboratories
by Rudi Visagie, from the Community
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.
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About author
This community page makes available free workplace checklists and templates created by other users within the SafetyCulture community. SafetyCulture has re-published this content and where possible, has credited the original author. SafetyCulture has not verified the accuracy, reliability or suitability of any community content. You agree that your use of any of this content is in accordance with SafetyCulture’s Terms and Conditions.