Validation of Data verification tool per 21 CFR 820

#1
I am currently trying to validate a custom software tool that will be used for snapshotting the states of different systems on the medical device that is undergoing V&V. In addition to generating the data, the software will also determine if the states are correct with a PASS/FAIL per our Design V&V protocol. The data printout will be attached to the test report as evidence and the manual tester will verify that all tests passed before signing off on the test script that was run.

My question is does this created data printout (which and calculates if the states are correct and then determines a PASS/FAIL) constitute an electronic record per 21 CFR 820, and is therefore required to conform to requirements related to audit trail, authority checks, protection of records.. etc?

Note: the printout will ultimately be attached to a test case report and then signed by the tester.
 
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#2
If a system is generating information that will be used to make a pass/fail decision, it needs to conform to all data integrity requirements.

So let's say I make widgets that need to be a centimeter long at their longest point. I have a piece of equipment that measures widgets, but does not export the data or make a pass/fail determination. I am now building a custom software tool that snapshots the equipment's measurement. If the measurement is >1cm, the custom software tool reports FAIL. If the measurement is <1cm, the software tool reports PASS. The measurements and pass/fail data are now printed and verified by a human operator.

In this case, I would say the printout is the original data. It needs to meet all data integrity requirements - (ALCOA+) attributable, legible, contemporaneous, original, accurate, available, complete, consistent, and enduring. Does the electronic version of the snapshot need to be saved as well? My gut instinct is no. As long as you have a full and complete representation of the data printed and preserved, I'm not sure what saving the snapshot gets you. If you choose to save the snapshots somewhere as documentation of compliance, I'd say they need the full protection, retention, etc.

The software taking the snapshots needs to have appropriate protections against people making changes to it.
 
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