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Kai

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  • Posts

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  • Country

    United States

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  • Occupation
    Blood Bank

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  1. It was on site validation to access the kiosk thru our hospital network to the validation environment. They validated the unit selection interface from SafeTrace to the HaemoBank and scanning functionality.
  2. We just used a 3rd party vendor to validate our HaemoBank. Korchek Technologies
  3. We will be switching blood bank systems in the near future. Does anyone know of a reputable vendor that can help with data conversion? Thanks,
  4. We used a third party vendor called Korchek Technologies because FDA recommends independence of review in section 4.9 of "General Principles of Software Validation; Final Guidance for Industry and FDA Staff". I've attached the document below FDA Validation Guidlines.pdf
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