Clinical and Laboratory Standards Institute document I/LA33-P–Validation of Automated Devices for ImmunohematologicTesting Prior to Implementation; Proposed Guideline provides guidance to the user and laboratory for validating an automatedsystem for immunohematologic testing. Current automated system methodologies are discussed. This document addresses thedevelopment of a validation plan and the information required for its creation. It includes guidelines for elements and tasks of thevalidation process, including installation qualification, operational qualification, and performance qualification. For each of thesequalifications, the purpose, prerequisites, responsibilities, considerations for and examples of test cases, and activities performedare included. The Appendix contains templates that may be used by the laboratory for development of test cases related to and fordifferent aspects of installation qualification, operational qualification, and performance qualification.
- Published:
- 04/01/2009
- ISBN(s):
- 1562386980
- Number of Pages:
- 92
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