Regulatory Open Forum

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  • 1.  Software Verification

    Posted 08-Dec-2021 12:07
    Hi All,

    I had a question regarding SW Verification protocols - is it required to document the method of verification used as an entry of its own, or will it be covered either in the textual description of the test or implicit in the testing being carried out? What have your experiences been so far w.r.t. the FDA?


    Akshay Kulkarni
    United States

  • 2.  RE: Software Verification

    Posted 08-Dec-2021 15:35
    Edited by Akshay Kulkarni 08-Dec-2021 15:34
    Should be more clear - by method of verification, I mean whether we should include which method of
    • Inspection (I): control or visual verification
    • Analysis (A): verification based upon analytical evidences
    • Demonstration (D): verification of operational characteristics, without quantitative measurement
    • Test (T): verification of quantitative characteristics with quantitative measurement
    was used.

    Thanks again!

    Akshay Kulkarni
    United States

  • 3.  RE: Software Verification

    Posted 09-Dec-2021 01:49
    Hello Akshay,

    Unfortunately your question is not so easy to answer in current context because this could be one of those or all of those methods depending on the type of software, level within the device, if SaMD, and/or risk involved.  The important point is in a software verification testing protocol, this would be clearly defined.  I would guess depending on some software the type of verification method might be implicit in the actual testing methodology, for example if a low level algorithm is being tested, then A and D (and maybe T) would be implicit.  Then in other cases, there may be software controlling sensors where a physical I or visual inspection would need to be clearly stated.  You are definitely on the right track to address IADT, apply this as appropriate to the software, the device, and the testing.

    Richard Vincins RAC
    Vice President Global Regulatory Affairs

  • 4.  RE: Software Verification

    Posted 28-Dec-2021 19:55
    Hi Akshay
        There are 3 Different Types of Verification for Software Applications  - called the Testing Pyramid.
    1) Unit Tests 
    2) API or Messaging Tests 
    3) UI or User /Usability Tests
     Specific to these Tests the Unit tests are not part of the Final Product and are done on a Development system as part of a Analysis or a Demonstration. A Test needs a Final Configured software with controlled variables/inputs dealing with Patient PHI/Test data and hence would be a valid Test - API and UI Tests depending on the level of complexity would be considered for Test.  The Inspection may cover code/ user interface that needs to match the Test Traceability between the SRS(Requirements) and Testcases.  Ideally the Test plan needs to identify and classify the types of Test validation.


    Vikram Upadhya
    Tech Lead
    MDD-MDR Transition
    HCL Tech

  • 5.  RE: Software Verification

    Posted 09-Dec-2021 04:26

    I would (and have/do) document the test methods in a verification test plan along with any required rationale.

    The protocols should then cover what was in the plan.


    David Clafton
    United Kingdom