What is the expectation for storing and archiving data that is generated during a test script?

COMPUTER SYSTEM VALIDATION (CSV)
1

Hi all, first post for me.

What is the expectation for storing and archiving data that is generated during a test script as part of a software validation.

If I execute a test script in a validation environment and generate screen prints or reports from a system, do I also have to maintain the electronic files associated with the test? Is the expectation the same as for a production environment, where I save and have archive procedures for all data and meta data. None of the validation data would be used to support a drug submission. The data is generated to prove user requirements.

2

If your test is going to be reviewed and approved electronically, then it make sense to maintain a file of all the screen shot evidences. Otherwise, you can print the screen shots as and when available. Regardless of how you produce and maintain a test evidence, following information should be present on the evidence at a minimum - Test Script ID, Step Number, Tester Signature and Date, Page number(s), Run#(if applicable)