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.
QUESTION: 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).
QUESTION: If it exists, can someone point me in the right direction to find the regulation on storing data?
Any insight is appreciated :)
Thank you,
Brandon Adkinson
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Brandon Adkinson
Waukesha WI
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