A CLIA laboratory desired to relocate their laboratory testing facility to a new larger facility. The laboratory requested assistance from Performance validation in the qualification of the facility and requalification of the moved laboratory and production equipment.
Performance Validation was engaged by the client and developed the validation plans, which addresses the qualification methodology of equipment within the four areas of : facility and utilities, production, clinical and research. The qualification plans addressed the division of responsibilities of development and execution between Performance Validation and client staff. Performance Validation responsibilities included the following activities:
- User Requirement, Installation Qualification, Operational Qualification, Summary development and qualification execution for the facility and utility systems including potable water, HVAC, electrical and backup generator equipment.
- User Requirement, Installation Qualification, Operational Qualification, Summary development and qualification execution for the walk-in controlled temperature units.
- Development of User Requirements, Infrastructure Qualification documents, and Network Qualification documents for the facility IT network.
- Development of URS and Verification or Installation/Operation Qualification of selected production equipment (execution by client).
- User Requirement, Qualification, summary development and qualification execution for the facilities Controlled Temperature Equipment including Freezers, Refrigerators, Chromatography Refrigerators, and Ultra Low Freezers.
- Additionally, Performance Validation CSV personnel were asked to assist in the qualification of the Laboratory Information Management System. See the project summary addressing the challenges when using vendor testing protocols.
The Results and Benefits
The qualification activities were satisfactorily completed within the allowable schedule and under budget. The facility relocated their operations to the new larger facility with minimal interruption to laboratory testing. Following relocation, the CAP audit/inspection was successfully completed and the ISO certification audit is forthcoming. The larger facility will enable the laboratory to increase production, and gain efficiency through consolidation of laboratory personnel in one common facility.
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Rick Van Doel