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Posted 03-23-2020 06:17
Hello Fellow CDMs,
Currently, I document and store all UAT procedures. This includes the UAT PLAN, DVP and an export of the subjects data. I realize this is done to ensure traceability for the testing.
Am I going above and beyond what is needed?
From what I read, I believe not, but I cannot find the regulation about testing, validation and traceability (namely storing the subject data).
If it exists, can someone point me in the right direction to find the regulation on storing data?
Any insight is appreciated :)
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