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Blood Warmer Validation


merky125

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This is what I have in my validation procedure.  The IQ (did we "install" it the way the manufacturer wants us to?) and OQ (does it do what the manufacturer says it does?) I get from the user's manuals.  The PQ is to make sure it opererates the way YOU need it to at your facility.

  1. Equipment only: prior to validation, the BioMed department will inspect the equipment and perform an electrical safety check.  The equipment will then be assigned a unique tracking ID#.  The following elements will be performed:
    1. Installation qualification: demonstrates that the equipment is properly installed in the environmental conditions specified by the manufacturer.
    2. Operational qualification: demonstrates that the equipment operates as intended.
    3. Performance qualification: demonstrates that the equipment performs as expected for its intended use and that the output meets expectations in a normal working environment.
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