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.
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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