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I have a unique question:
We are planning to use a software to generate reports by searching some SAS datasets which contain study information (like AEs, demographics, etc). These reports are primarily for internal use (not submitted to FDA) but one important point is that we may use this information to see whether we need to increase or decrease or stop drug during clinical trials. Question is: does this system/software need to be validated and if yes, to what extent? (By "what extent" I mean that is it absolutely necessary to involve computer system validation expert to certify that one or all of the output reports are complete and do indeed process the entire data that it accessed from the SAS dataset?)
Please point me to the right forum if this seems to be a bit off!
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