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Qualification and validation of software and computer systems in laboratories

Part 1: Validation during development

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Abstract

Software and computer systems are tested during all development phases. The user requirements and functional specifications documents are reviewed by programmers and typical anticipated users. The design specifications are reviewed by peers in one to two day sessions and the source code is inspected by peers, if necessary. Finally, the function and performance of the system is tested by typical anticipated users outside the development department in a real laboratory environment. All development phases including test activities and the final release follow a well-documented procedure.

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© 1997 Springer-Verlag

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Huber, L., Wiederoder, H. (1997). Qualification and validation of software and computer systems in laboratories. In: De Bièvre, P., Günzler, H. (eds) Validation in Chemical Measurement. Springer, Berlin, Heidelberg. https://doi.org/10.1007/3-540-27034-5_4

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