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- W2186355297 abstract "When outputting data and/or statistics with the SAS software®, the regulatory requirements mean that validation of these outputs has to be performed to ensure their accuracy. One of the most common processes used for validation is independent/duplicate programming. As a result of this method, Validation Forms are to be used as well as Tracking Forms to document the progress of the Development programs as well as the Validation programs. While necessary, this documentation procedure can be very time-consuming and therefore creates a need to automate the production of this documentation as much as possible. In this paper, I will describe how, from a shared Tracking Excel file where every programmer can enter his progress on his own program, a validation package is created and automatically transferred to a secure Archive location. This package includes the SAS programs, outputs and logs. The signed Validation forms can automatically be generated whenever the person in charge of the validation confirms that the process is complete. In addition, they are e-mailed and put together in that same secure location. I will present a possible structure for the tracking file and the options necessary in the validation forms so that the forms corresponding to a validated program can be created automatically using some Visual Basic® code." @default.
- W2186355297 created "2016-06-24" @default.
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- W2186355297 date "2008-01-01" @default.
- W2186355297 modified "2023-09-26" @default.
- W2186355297 title "Automating Production of Validation Documentation" @default.
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- W2186355297 hasPublicationYear "2008" @default.
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