In the blood bank world, validation refers to evaluation to make as sure as possible that a particular process will perform as expected. Many people think of validation as only making sure that a particular piece of equipment is giving appropriate results, but the broader definition includes the entire process, not just the equipment. Objective evidence that results in a “high degree of assurance” that the process is in fact meeting expectations is required. When dealing specifically with equipment, validation includes several specific “qualification” steps, including “installation qualification,” “operational qualification,” and “performance qualification” (see the linked definitions for each term). Most importantly, validation is not a haphazard process. An approved written plan, or “validation protocol,” is an essential part of putting a new process or piece of equipment into use.
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