How to manage documents in Jama?

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Omer Messenberg
Omer Messenberg Member, Medical Devices & Life Sciences Solution Posts: 27
edited March 2022 in

Hi,

We would like to hear from other medical devices companies about the best practices for their Test management in Jama.

Where it better to write tests and plans : in the Test Plan area or in the Explorer tree for easier review and export to create documents like protocols and reports (V&V) and STD,STP,STR (SQA)?

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  • Patrick Szabo
    Patrick Szabo Member Posts: 49
    edited March 2022
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    Hi Omer,

    we are a medical device company and we use the explorer tree only to create and collect the test cases, but the Test Plan area for writing test plans and executing the tests and we have our own velocity report templates for both, test plan and test report.

    The test plan template basically exports the content of the test plan overview and all the test cases grouped by the test groups, but without any results. The test report template then exports the test plan overview and all the test runs, grouped by test cycle.

    In the Test Plan area, we create separate Jama test plans for a "test plan" and a "test report". A "test plan" test plan is not executed and it only contains the test groups with the test cases. It is only used to create and export the test plan document for approval. A "test report" test plan then contains the exact same test cases and test groups, but including the test cycles and executed test runs with the results. In our case, the overview section for a "test plan" test plan is different to what is in the overview section for a "test report" test plan with results. Therefore, we have also created two different editor templates for that. Depending on the type of test plan, we select the respective template before filling out the respective content in the test plan overview.

    Regards
    Patrick
  • Omer Messenberg
    Omer Messenberg Member, Medical Devices & Life Sciences Solution Posts: 27
    edited March 2022
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    Hi Patrick, 

    Thank you for the response.
    How do you dill with the appendixes section in the test plan?
    In the protocol they should appear after the test cases, but currently all our overview section is in the content field. 
    Do you put this section in another field? 

    Thanks, Omer.
  • Patrick Szabo
    Patrick Szabo Member Posts: 49
    edited March 2022
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    We don't have an appendixes section in our test plan. We basically just have a table referring to any external documents.

    But you could add a separate rich text field "Appendixes" to the test plan item type and create a velocity report template, which exports the content of this field after all the test cases.

    For creating our velocity report templates, I used the following community reports from Jama as base and modified it to fit our own corporate document template and to also have our custom fields inside:
    Test Plan Report
    Test Results Report - Grouped by Test Cycle
    Patrick
  • Jacob Brodal
    Jacob Brodal Member Posts: 10
    edited March 2022
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    Hi Patrick,
    How do you deal with approval / signature of the test results report?

    Is it something you add at a later point?

    CFR 820.30(d) requires both the signature and date of approval.
  • Patrick Szabo
    Patrick Szabo Member Posts: 49
    edited March 2022
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    Hi Jacob,

    we have a signature table included in the Editor Template and we simply print the report and collect the signatures with respective date of approval.
    Patrick
  • Per Ekvall
    Per Ekvall Member, Jama Validation Kit (JVK) + Functional Safety Kit (FSK) Posts: 11
    edited March 2022
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    Patrick You mean that you write signatures manually on the paper after print out?

    Then it is impossible to follow what is approved and what's not?

  • [Deleted User]
    [Deleted User] Posts: 15
    edited March 2022
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    Folks, I appreciate the discussion but it doesn't belong in the Release Notes and Announcements forum.

    Jama moderators: is there any way to move this thread in its entirety to the correct forum?

    Thanks, and sorry for the +1 spam,
  • Carly Rossi
    Carly Rossi Jama Staff Posts: 170
    edited March 2022
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    Thanks for the feedback, @Chris Eich, and for the discussion so far, @Omer Messenberg@Patrick Szabo, @Jacob Brodal, and @Per Ekvall. I've moved this thread to Product Discussion; feel free to continue the conversation there!
    Carly Rossi // she/her/hers
    Community Program Manager // Jama Software
    Portland, OR
  • Patrick Szabo
    Patrick Szabo Member Posts: 49
    edited March 2022
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    Per,
    our processes are still very "analog" in this case and might not be considered as best practice. We don't pay attention to the approval workflow within Jama. For our QA, only paper matters. That's why we really collect signatures manually after print out. At least QA accepted to use the digital signature feature provide by Adobe Acrobat within a pdf, as collecting physical signatures during the pandemic and with most of the stakeholders working from home was almost impossible.

    But once we have exported the document and collected the "manual" signatures on the pdf, we still create a baseline in Jama for the content so that we can do easier comparisons between different document versions.
    Patrick