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:
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.
For additional information please contact:
Rick Van Doel
President, Performance Validation, LLC.
5420 W Southern Ave, Suite 100
Indianapolis, IN 46241
(317) 248-8848 x148
(317) 507-0351 Mobile