Regulatory Open Forum

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  • 1.  Software validation

    Posted 06-Mar-2019 08:57

    Good morning,

    Curious to know what everyone's approach has been for software validation. More specifically when have you performed software validation in relation to clinical trials? Before phase 3 clinical trials? Software verification would be completed before any trials.
    This would be for a combination product (drug/device combination product, PMOA is based on the drug).

    Looking forward to your feedback.

    Thanks,

    Sabrina  



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    Sabrina Dessources
    Boston MA
    United States
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  • 2.  RE: Software validation

    This message was posted by a user wishing to remain anonymous
    Posted 07-Mar-2019 00:05
    This message was posted by a user wishing to remain anonymous

    ​Yes, we did software validation before human use... for safety. Is there a risk?
    Original Message


  • 3.  RE: Software validation

    Posted 07-Mar-2019 08:40
    For a drug/device combo where the drug is the PMOA, I would highly recommend completing the software validation on the device prior to starting the clinical trials.  With that said, you could do software verification, then do some initial software validation follow-on with software validation through the clinical trial.  However, all safety features and operations should be tested in that initial software validation - think of it as a staged or phased approach.  However, I would not recommend that because the software should be "finished" going into the clinical trials.  I do not say final because software is never finalised, but it should be in a finished, stable state.  You do not want to have to go back to the regulator during the middle of a clinical trial telling them you had to revise the software which may put all the data you accumulated so far in the clinical trial in jeopardy. The regulations will never state when this should be done, so you have to consider the regulatory and business risks with doing software validation during the clinical trial.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Software validation

    Posted 08-Mar-2019 21:06

    ​Thanks everyone!

    Richard thanks for the detailed feedback. In a nutshell, some of what you stated was our plan i.e. extensive design verification testing has been performed and the SW is in its "finished" state. SW "validation" to be completed during trials. 

    Thanks,

    Sabrina  



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    Sabrina Dessources
    Boston MA
    United States
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    Original Message


  • 5.  RE: Software validation

    Posted 07-Mar-2019 08:48
    Hello,

    Since you didn't mention the trial type (device/pharma) or use of software, it's difficult to advise.  However, I think if you have a look at ICH Q7  as well as ICH E6 (R2), that may get you started.

    Best,
    Gretchen

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    Gretchen Upton RAC
    RA/QA
    TX
    United States
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    Original Message


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