I am new to SpiraTest and have almost figured out how to make SpiraTest work within 21 CFR Part 11 (medical devices). I have a few remaining questions Im hoping someone may have good pointers on: We have User-Needs which get Validated. Each User Need consists of one of more Requirements which get Verified. My plan is to just indent the Requirements and leave the User Needs as top-level requirements. My concern is that when all requirements are tested, the tool will show the User Need (top level) as having been tested. But I want to require a separate Validation for all top-level User-Needs. Any suggestions on how to implement this? Second and last question: Looking for best practices on versioning test case protocols. I can add a custom version field to the test case and require a signature to release it. If I then want to edit it, I was thinking of cloning the test case, resetting the status to not approved (or whatever), and incrementing the version number. Anyone have experience with this workflow and potential pitfalls? This would result in one requirement being tested by multiple test cases (different version number)... I think thats ok. Appreciate any feedback. Thanks -Ed Each USER NEED gets translated into several REQUIREMENTS (SRS for Software and REQs for Hardware). REQUIREMENTS get Verified. USER NEEDS get Validated. I was going to put all User Needs as the top level Requirements, and the Requirements would be indented. My concern is that if all requirements are tested, it will show the User Need as having been tested. 1) I will add a required signature to release a Requirement. Great. Now I want to release Version 2 of the requirements in our document control system so I will have SpiraTest output a list of requirements in PDF format so check-in. In the check-in process (we use Arena), we always need to say: What changed since the last approved version. Is there a way I can filter requirement based on when they were edited? As in: Show me all requirements which were edited since I released the first version? en-US(C) Copyright 2006-2026 Inflectra Corporation.support@inflectra.com/Computers/Software/Project_Management//Computers/Software/Quality_Assurance/KronoDesksupport@inflectra.comhttp://www.inflectra.com/kronodesk/forums/threads120/Support/Forum/spiratest/issues-questions/2168.aspxthreadId=2168Ed Landau (ed@isonohealth.com)validation verification versioning I am new to SpiraTest and have almost figured out how to make SpiraTest work within 21 CFR Part 11 (medical devices). I have a few remaining questions Im hoping someone may have good pointers on: We have User-Needs which get Validated. Each User Need consists of one of more Requirements which get Verified. My plan is to just indent the Requirements and leave the User Needs as top-level requirements. My concern is that when all requirements are tested, the tool will show the User Need (top level) as having been tested. But I want to require a separate Validation for all top-level User-Needs. Any suggestions on how to implement this? Second and last question: Looking for best practices on versioning test case protocols. I can add a custom version field to the test case and require a signature to release it. If I then want to edit it, I was thinking of cloning the test case, resetting the status to not approved (or whatever), and incrementing the version number. Anyone have experience with this workflow and potential pitfalls? This would result in one requirement being tested by multiple test cases (different version number)... I think thats ok. Appreciate any feedback. Thanks -Ed Each USER NEED gets translated into several REQUIREMENTS (SRS for Software and REQs for Hardware). REQUIREMENTS get Verified. USER NEEDS get Validated. I was going to put all User Needs as the top level Requirements, and the Requirements would be indented. My concern is that if all requirements are tested, it will show the User Need as having been tested. 1) I will add a required signature to release a Requirement. Great. Now I want to release Version 2 of the requirements in our document control system so I will have SpiraTest output a list of requirements in PDF format so check-in. In the check-in process (we use Arena), we always need to say: What changed since the last approved version. Is there a way I can filter requirement based on when they were edited? As in: Show me all requirements which were edited since I released the first version? Fri, 17 Apr 2020 17:13:35 -04002020-04-17T17:34:19-04:00/Support/Forum/spiratest/issues-questions/2168.aspxmessageId=3766Ed Landau (ed@isonohealth.com) Sorry... that was my scratch pad at the end there... no way to edit the post. Bummer. Fri, 17 Apr 2020 17:15:10 -04002020-04-17T17:15:10-04:00/Support/Forum/spiratest/issues-questions/2168.aspx#reply3766messageId=3767David J (adam.sandman+support@inflectra.com) Hi Ed, I would recommend you email support@inflectra.com or log a help desk ticket for this. Feel free to copy the text into the ticket or email. The forums are not monitored as frequently as the help desk. Regards David Fri, 17 Apr 2020 17:34:19 -04002020-04-17T17:34:19-04:00/Support/Forum/spiratest/issues-questions/2168.aspx#reply3767