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- W2076936531 abstract "Abstract This paper will interpret the application of the different quality standards like Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and ISO 9000-3 guidelines to computer systems. The ISO 9000-3 contains requirements for developing software, whereas the GxPs have more detailed requirements for use. ISO 9000-3 can be used profitably as a tool for the GxPs. The standards often have vague demands which need to be interpreted. The wordings of the standards are compared to current interpreted requirements. Tables for comparison of the wording of the standards are also included." @default.
- W2076936531 created "2016-06-24" @default.
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- W2076936531 date "1995-09-01" @default.
- W2076936531 modified "2023-09-28" @default.
- W2076936531 title "Quality assurance of computer systems what is needed to comply with ISO 9000, GMP, GLP, and GCP?" @default.
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- W2076936531 doi "https://doi.org/10.1016/1381-141x(95)80011-q" @default.
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