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  • 1.  Quickbase platform

    This message was posted by a user wishing to remain anonymous
    Posted 08-Mar-2023 08:19
    This message was posted by a user wishing to remain anonymous

    Hello everyone, 

    I would appreciate your input here. 

    we are a small IVD manufacturer company based in EU. We are planning to introduce QuickBase platform as a system to record our meetings, actions, annual leaves etc..Are there specific regulatory requirements we need to meet to have this platform within our system? Do we need to refer to this platform in our QMS? 

    THANKS.



  • 2.  RE: Quickbase platform

    Posted 09-Mar-2023 23:45

    hello, I dont think so!! I don't see any device function. It has to have a medical purpose. I hope I understood your question correctly!



    ------------------------------
    Jinali Bhavsar RAC
    Sr Regulatory Affairs Specialist II
    San Jose CA
    United States
    ------------------------------

    Original Message


  • 3.  RE: Quickbase platform

    Posted 10-Mar-2023 10:20

    Hi,

     If you are going to use this quick platform for ERP or manufacturing, warehousing, distribution or even storing any quality document then it needs to be referenced in QMS and may be even validated then.



    ------------------------------
    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
    ------------------------------

    Original Message


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