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Unvalidated database with our validated software system?

Discussion in 'IEC 62304 - Medical Device Software' started by Carloz Sanchez, Jun 27, 2022.

  1. Carloz Sanchez

    Carloz Sanchez New Member

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    Hello!


    I wonder if you can answer a question. Is it ever ok to use an unvalidated database with our validated software system? I say no, but is there any way? Is the integration even possible? Or do the Unvalidated partner must validate their system to be compliant with MDR?
     
    Carloz Sanchez, Jun 27, 2022
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  2. BradM

    BradM Moderator Staff Member

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    Hello Carloz! Welcome to the forum.

    How was the software system validated? What kind of software? Is the software validated to operate with independent databases?

    I guess the way I'm thinking... part of the validation of the software is that it operates as your business needs require (performance qualification). How can you assert that it operates appropriately without using the working data?
     
    BradM, Jun 27, 2022
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  3. yodon

    yodon Well-Known Member

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    Are you saying the database is external to your system and completely out of your control? If that's the case then I think all you can do on your side is ensure that your system validates the data coming in before using it.

    This may get a bit deeper. How do you ensure the schema isn't changed?
     
    yodon, Jun 27, 2022
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  4. Carloz Sanchez

    Carloz Sanchez New Member

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    Thank you for your answer! Well, the Software we sell is an information handler that is validated as class 1, but the client that wants to use our service has an unvalidated patient database. Now the question for me is: can we sell them our services and let him use it with his database or is the responsibility on us to see if his database is validated before he can use our system?
     
    Carloz Sanchez, Jun 28, 2022
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  5. Carloz Sanchez

    Carloz Sanchez New Member

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    Thank you for your help! Well, the (patient) database is entirely in the ownership of the user, we can make it work technically, but how do we validate the data coming in before using it?
     
    Last edited: Jun 28, 2022
    Carloz Sanchez, Jun 28, 2022
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