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5GAM

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  1. 5GAM

    New QC manufacturer for blood bank automated analyzer

    5GAM posted a topic in Transfusion Services
    Hello everyone, We will be moving to a new manufacturer for daily QC to be run on the blood bank gel analyzer. I need help on what the validation plan should include in order to establish the new QC works as expected. Any advice, details or examples would be very helpful. Thank you.
  2. 5GAM

    Question FDA guidance "Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels"

    5GAM posted a topic in Computer Systems / Software / ISBT128
    Hello Group, I am new to the transfusion area and just came across this document. I would like to know what is the process to determine if the recently released FDA guidance (regarding ISTBT v4.0.0) is applicable to blood bank lab. Thank you and appreciate any help.

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