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Defines precisely and clearly what the user expects the system to do. The document contains information about the operating environment, the required data for processing, and the functionality that the system should carry out. Additionally, the URS can contain non-process-related topics, such as processing time requirements, cost, etc. In a regulated environment, the URS should have a reference on the GxP regulation and must interpret it.
Publication Source: ISPE Good Practice Guide: Interactive Response Technology
Publication Date: 2011
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