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

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.

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.

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.