Report test run with signature + date

Per Ekvall
Per Ekvall Member, Jama Validation Kit (JVK) + Functional Safety Kit (FSK) Posts: 10
edited March 13 in Peer-to-Peer Support Forum

I have tried to understand if there are any way to get a report out of the tool that can be submitted to external notified body, BSI including everything about a specific test run including the Electronic signature. There are good reports for printing out everything about a review including runs but not a single run.

The report shall include the signature ( if it is reviewed in review center) Name + date 
The same regarding a test case + upstream links.

I've checked the database scheme and can not figure this out.

Is there nobody else using JAMA for Medical device where this is a common type of reporting necessity.

Comments

  • Jacob Brodal
    Jacob Brodal Member Posts: 11
    edited February 2022
    Hi Per,

    +1 for us at 3Shape, not just when it comes to test runs, but also for general export of requirements, V&V, etc. for submission.

    We were hoping that there was a standard set of reports to use, but it seems none of them allow for showing the electronic signature / name of approver. In a previous post in the Jama Community, I was told that this would require a custom Velocity Report.
  • [Deleted User]
    [Deleted User] Posts: 71
    edited February 2022
    Hi Per,
    this may be a bit of a philosophic answer, but: In contrast to a digital signature (like a certificate applied to a PDF document), an electronic signature lives only inside the system it has been applied in. So when you export something that has an electronic signature on it, there is no way a recipient of the document can verify the signature - it is just text. Jama only supports electronic signatures (i.e. let users enter username and password again on certain transitions to verify that the correct user has "signed"). So if you need signatures on the report then you will need to do something else anyhow. We export the artifacts we need for external submissions into PDF and sign them digitally.  We have developed our own solution which utilizes Jamas REST interface - unfortunately the interface is not open to the review center, but as the signatures applied to a review will actually applied to the baseline the review creates, it is possible to get the information about who signed the document.

    Maybe this information helps you :-)

    Regards
    Anna
  • Per Ekvall
    Per Ekvall Member, Jama Validation Kit (JVK) + Functional Safety Kit (FSK) Posts: 10
    edited February 2022

    Thanks a lot Anna,
    My conclusion is almost the same, use the procedure as you do, put the report into document system , sign it and "print" the report. This solution feels like a very complicated process , even worse to not sign at all and just keep everything as document instead.
    May I ask  what REST interface is? 

    I did an the export of a review that includes parts of a run and include the baseline review signatures. But the problem is that it not can be a single item (ex. a run or test case) as long we do't want to "re"- approve all single submissions one by one.

    The report lacks some fields as well and i can't find anywhere to upgrade the report, do you know where the report is defined?


    Export v1 review report---------------------
    Per Ekvall 

    AMBU A/S 
    --------------------
  • [Deleted User]
    [Deleted User] Posts: 71
    edited February 2022
    Hi Per,
    I assume you are using the built in Word reports. I am not so familiar with them, because we have written our reports ourselves from the very beginning, using the Velocity API Jama provides. But I recall there is some sort of boilerplate template than can be modified to add or remove fields from whatever you are exporting.
    As we have not been very happy with what Jama provides out-of-the-box for several reasons, we have now developed our own reporting engine, which basically combines the templates that are required by our QM system and the content we generate from Jama. It utilizes the REST interface of Jama, with basically is a way of querying Jama through an http-request and Jama will return a standardized Json-object. Those Json-objects can then be processed by other programming languages and they can then output any desired sort of document. 

    Hope this helps,
    Anna
  • Alessandro Valli
    Alessandro Valli Member, Data Exchange, Jama Connect Interchange™ (JCI) Posts: 789
    edited February 2022
    Hi Per,
    We adopt a procedure similar to Anna's. I have to remark I am not working in the field of medical devices.

    I have implemented a custom velocity report in which you get the evidence that the two-man-rule was adopted (for each single item).
    This relies to our way we perform reviews in Jama (process, not tool)
    This report protocol get saved together with the document in our document management system. Here we have again a workflow.

    Thus we have
    • a review in Jama (related to items)
    • export of document + report
    • an additional approval loop (this time a document, not items) in the document management system
     Best regards,
    Alessandro
    Alessandro
    Systems Engineer
    SICK AG
  • [Deleted User]
    [Deleted User] Member Posts: 4
    edited February 2022
    Hello.

    Really interesting discussion... We did the same as Alessandro.
    • a review in Jama (related to items) -> baselines created
    • export of documents + reports (from baselines to Word)
    • an additional approval loop (this time a document, not items) in the document management system (Word enhanced -> PDF)
    Because there is a lot of problems from Word templates and automation with the 3rd tier software, we are currently changing this to the following:
    • a review in Jama -> baselines
    • export of reports from the baseline to a new "container" of JAMA (API REST for everything except review reports)
    • approval loop in JAMA (with "workflows & transitions" provided in containers) (Web based workflow)
    • exports of signed reports which are extracted from the container (API REST -> PDF in the container)
    And without the "Word" temporary produced, less problem of formatting.

    I hope it will help people not to lose time like we did with JAMA web based integration, exporting files + signatures...
  • Dimitrios Pananakis
    Dimitrios Pananakis Member, Jama Validation Kit (JVK) + Functional Safety Kit (FSK) Posts: 57
    edited February 2022
    Hi Samuel,
    Thank you for sharing your method. I am puzzled about your solution. When you say you export reports from the baseline to a new "container" of JAMA,
    1. do you generate reports using some of the community BIRT/Velocity reports?
    2. how do you store those reports in a Jama "container"?  Are you adding them as attachments to items in Jama?
    Best regards
    Dimi
  • [Deleted User]
    [Deleted User] Member Posts: 4
    edited February 2022
    Hello.
    1)
    When we have the possibility, we export everything using API REST py-jama library (all JAMA items accessible with python). Only the reports from reviews (because no possibility to catch them with API REST), we use velocity/BIRT reports.
    2)
    I call container an item JAMA, that the only function is to contain attachments. In our case, we put inside a container:
    • the document generated from a baseline (using py-jama)
    • reports from the review (using velocity report)
    • other proofs
    Great now, this item/container can be associated with a workflow, then you can put different status to this container, (and with py-jama, even transform it into a signature...).
  • Benno Kusstatscher
    Benno Kusstatscher Member Posts: 23
    edited October 2023

    Interesting!

    "When we have the possibility, we export everything using API REST py-jama library (all JAMA items accessible with python). Only the reports from reviews (because no possibility to catch them with API REST), we use velocity/BIRT reports."

    Are you saying that with REST API one can only go as far as getting the review id (GET /baselines/{baselineId}/reviewlink) and that there is no REST counterpart for the getSignaturesForBaseLine Velocity command?

    For a while I am trying to write a REST script that confirms that all work products of interests have been properly signed by the key people, but I am stuck. Are you triggering the Velocity report by the REST script automatically, or are these all manual steps.

    ------------------------------
    Benno Kusstatscher
    Analog Devices
    ------------------------------
    -------------------------------------------
    Original Message:
    Sent: 02-17-2022 06:13
    From: Samuel LE COZE ULSHYNA
    Subject: Report test run with signature + date

    Hello.
    1)
    When we have the possibility, we export everything using API REST py-jama library (all JAMA items accessible with python). Only the reports from reviews (because no possibility to catch them with API REST), we use velocity/BIRT reports.
    2)
    I call container an item JAMA, that the only function is to contain attachments. In our case, we put inside a container:
    • the document generated from a baseline (using py-jama)
    • reports from the review (using velocity report)
    • other proofs
    Great now, this item/container can be associated with a workflow, then you can put different status to this container, (and with py-jama, even transform it into a signature...).

    ------------------------------
    Samuel LE COZE ULSHYNA
    Mercury Missions System Intl
    Geneva
    ------------------------------

    Original Message:
    Sent: 02-16-2022 12:10
    From: Dimi Pananakis
    Subject: Report test run with signature + date

    Hi Samuel,
    Thank you for sharing your method. I am puzzled about your solution. When you say you export reports from the baseline to a new "container" of JAMA,
    1. do you generate reports using some of the community BIRT/Velocity reports?
    2. how do you store those reports in a Jama "container"?  Are you adding them as attachments to items in Jama?
    Best regards
    Dimi




    ------------------------------
    Dimi

    Original Message:
    Sent: 02-16-2022 06:54
    From: Samuel LE COZE ULSHYNA
    Subject: Report test run with signature + date

    Hello.

    Really interesting discussion... We did the same as Alessandro.
    • a review in Jama (related to items) -> baselines created
    • export of documents + reports (from baselines to Word)
    • an additional approval loop (this time a document, not items) in the document management system (Word enhanced -> PDF)
    Because there is a lot of problems from Word templates and automation with the 3rd tier software, we are currently changing this to the following:
    • a review in Jama -> baselines
    • export of reports from the baseline to a new "container" of JAMA (API REST for everything except review reports)
    • approval loop in JAMA (with "workflows & transitions" provided in containers) (Web based workflow)
    • exports of signed reports which are extracted from the container (API REST -> PDF in the container)
    And without the "Word" temporary produced, less problem of formatting.

    I hope it will help people not to lose time like we did with JAMA web based integration, exporting files + signatures...

    ------------------------------
    Samuel LE COZE ULSHYNA
    Mercury Missions System Intl
    Geneva

    Original Message:
    Sent: 02-10-2022 06:36
    From: Alessandro Valli
    Subject: Report test run with signature + date

    Hi Per,
    We adopt a procedure similar to Anna's. I have to remark I am not working in the field of medical devices.

    I have implemented a custom velocity report in which you get the evidence that the two-man-rule was adopted (for each single item).
    This relies to our way we perform reviews in Jama (process, not tool)
    This report protocol get saved together with the document in our document management system. Here we have again a workflow.

    Thus we have
    • a review in Jama (related to items)
    • export of document + report
    • an additional approval loop (this time a document, not items) in the document management system
     Best regards,
    Alessandro

    ------------------------------
    Alessandro
    Systems Engineer
    SICK AG

    Original Message:
    Sent: 02-08-2022 03:55
    From: Per Ekvall
    Subject: Report test run with signature + date

    I have tried to understand if there are any way to get a report out of the tool that can be submitted to external notified body, BSI including everything about a specific test run including the Electronic signature. There are good reports for printing out everything about a review including runs but not a single run.

    The report shall include the signature ( if it is reviewed in review center) Name + date
    The same regarding a test case + upstream links.

    I've checked the database scheme and can not figure this out.

    Is there nobody else using JAMA for Medical device where this is a common type of reporting necessity.

    ------------------------------
    Per Ekvall [Designation]
    AMBU
    Ballerup
    +45 7225 2704
    ------------------------------

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