Medical Device Software Verification and Validation Results - What is necessary?

S

singber

#1
The verification and validation results of our medical device software testing are stored online in a (homegrown) testing tool. Currently we generate testing summary reports which include the ID of each test case, test case name, tester ID, test case result (pass/fail) and and related defects. At the end of each report are summary statistics (test case pass/fail rate, and defect criticality statistics). My director wantas to remove the test case detailed information and just leave it with the statisitics table, defect information, and total number of test cases run. I don't think this is enough detail. The results are in the online system, but would inspector really be happy with that answer? Any thoughts/comments are appreciated!

Sean
 
Elsmar Forum Sponsor
D

Duke Okes

#2
Re: Verification/Validation Results - what's necessary?

Can't inspector ask to see detailed online info if desired?
 
S

singber

#3
Yes, but the summary reports provide a snapshot of teh results when testing was completed. Those results can be modified in the system by those with appropriate access. There is an audit trail but it's not apparent that something was changed unless someone looks in the audit trail.
 

Chris Ford

Quite Involved in Discussions
#5
How much data is need during validation. For example is it ok to have:
1. Test steps
2. Pre-populated expected results

Run the test script and just document Pass or Fail?
The complexity of the protocol should be commensurate with the complexity of the software you're validating. I just validated some workflows in Agile, and that's pretty much what I did. The users had to create records, but most of the protocol results were pass/fail.
 
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