[Validation of a computer-assisted procedure for producing blood and blood component transfusions].

Abstract

Background: The validation of computer-aided methods in the production of stored blood and blood components represents for a pharmaceutical institution a basic condition for the carrying out of the decrees of pharmaceutical companies. When validating computer-aided methods in medicine or pharmacy, the fields of informatics and technology have to be linked to applications in medicine and pharmacy.

Method: In many cases the methods for the documented proof that a system achieves the expected capacity are too complex, so that a validation is only practicable in module groups. This is shown with an example of the blood typing on microtiter plates.

Results: After the selection of the hard- and software according to the safety criteria of information technology taking into consideration functional classes and degrees of quality, a complete documentation of the validation of blood typing on the microtiter plate was carried out.