Analytical laboratory quality: Part II. Analytical method validation.
The most important objective to be met by an analytical testing facility is to have confidence in the data it generates. Most laboratories devote considerable energy to insure that test methods are appropriate, instruments are operational, and the training of analysts is adequate. Experienced scientists will design suitable internal controls in each analysis to confirm the success of a test. Good laboratory managers will monitor the status of facility operations to detect negative trends in the routine performance of instruments, methods, or analysts. Validation, a study designed to insure that a system is suitable for its intended use, is another mechanism that a facility can utilized to enhance confidence that the methods and instruments being used are capable of generating valid results. Additionally, using a validation protocol as a training tool can serve as an excellent manager/mentor mechanism for each type of technology employed in the laboratory. Finally, the generic validation of representative (surrogate) materials allows ongoing assessment of performance attributes independently from the wide variety specific sample types seen by core facilities.
Ritter
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NM
Quality and Compliance Group, Association of Biomolecular Resource Facilities, Rockville, MD, USA. NRITTER@bioreliance.com
Hayes
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Dougherty
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