Regulatory Open Forum

 View Only

  • 1.  Testing results and DHF

    Posted 21-Jun-2023 09:26

    We are currently in stage Beta, and we have test results from the IT team and the research and development team. Are we supposed to compile all of these test results into a single document control format and store them in DHF like we did in stage 0? I'm not sure how to do that, especially since we're planning to conduct a design review within the next month. 

    Thank you for your corporation ! 



    ------------------------------
    Nawal Tiouri
    Quality & Regulatory Engineer
    Ypsilanti MI
    United States
    ------------------------------


  • 2.  RE: Testing results and DHF

    Posted 21-Jun-2023 11:30

    No, there is no requirement to compile them into a single document.

    For each test (or combination of tests) you should have a test plan and a test report. Each of them goes into the DHF. If there are multiple revisions, they all go into the DHF. In FDA QSR the DHF is a compilation of records which describes the design history of a finished device.



    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 3.  RE: Testing results and DHF

    Posted 22-Jun-2023 05:36

    Hello Nawal,

    This depends on how you want to structure or document the testing results in the Design History File (DHF).  In a "beta" testing this could be viewed as Verification testing and so again, really document as needed.  Recommend identifying these testing results in reports which have a document identification number which can be viewed and traceable in the DHF.



    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 4.  RE: Testing results and DHF

    Posted 22-Jun-2023 11:23

    Hi Nawal, 

    I agree with above comments. You dont have to compile everything in one document, but it is a good practice to have a Summary V&V Report (or Master Report) where you reference all testing/validation done, including a brief description of the purpose and overall results (pass/fail). This is very helpful for future submissions.

    Also, make sure you have a traceability matrix document. Meaning you identify the requirement (user requirement, system requirement, RM, etc.) and the corresponding test plan/protocol, test report, and a pass/fail. Also be sure to identify the Beta model in all documents, to clearly distinguish results obtained from prototypes or final design.

    Daniela



    ------------------------------
    Daniela Mahan Soler Esq, RAC
    Quality and Regulatory Affairs Manager
    Munich
    Germany
    ------------------------------

    Original Message


  • 5.  RE: Testing results and DHF

    Posted 23-Jun-2023 09:38

    Hi Nawal,

    I hope the above comments give you a direction. Whichever way you organize your test files, make sure that the traceability is established as Daniela Mahan mentioned in her comment. That is the Key!

    Thank you,

    Sravan



    ------------------------------
    Sravan Kumar Manchikanti, RAC
    Hyderabad
    India
    ------------------------------

    Original Message


Related Content