[Criteria of good manufacturing practice conforming electronic data processing].
Good manufacturing practices (GMP) are not only supported by data management systems but also implicate that they must meet the supplier qualification criteria in terms of GMP. Elements which technically support a GMP-conformity are multiuser-operating systems, relational data bases, object-oriented languages and data parameters. The most important part is covered by human resources of a bloodbank, which starts with the definition and ends with validation tests. Only the required profile of the end-user makes the GMP-conformity of a data management system constructable and realizable. Competence in project-management and clearly structured projects let such systems perform as planned.
Gabriel
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Blutspendedienst des Roten Kreuzes für Oberösterreich, Blutzentrale Linz, Osterreich.
D001771:Blood Banks / Q000458:organization & administration*; D003199:Computer Systems; D003628:Database Management Systems; D001330:Electronic Data Processing; D006801:Humans; D011785:Quality Assurance, Health Care; D012985:Software Design
Kriterien einer GMP-konformen EDV.