Hello all,
my name is Elif and i`m a working IT-student a big pharma-company in Switzerland. We are very interested in using the software Jira for our requirements-management. But according to very strict pharmaceutical GMP guidelines and the law, the software we will use have to fulfill some requirements. For example the software has to enable electronic signature and fulfill the part 11 guidelines from the FDA. Does Jira have certain functionalities that must be fulfilled from a validation point of view? The functionalities are following:
--> It should be possible to define in the system that passwords periodically expire and need to be revised
--> Are electronic records possible? Records should be protected against intentional or accidental modification or deletion. And upon making a change to an electronic record, the previously recorded information shall still be available. So far an electronic record’s audit trail should be retrievable throughout the record’s retention period.
--> Possibility of an electronic signature. The electronic signature should be made up of at least two components, such as an identification code and password.
--> An approval and review-process to approve / review workitems.
--> If an workitem is denied, an change-process should initiate including a change-request-review and -approval.
--> It should be possible to create test cases. It should be possible to review and approve the testcase and block it for editing before the test execution. It shall be possible to execute approved test cases and provide test outcome as actual result per test step. There should also be available test result categories.
--> A risk assessment should be carried out for each GxP critical requirement.
Thank you very much for your support!
