SIG - FDA Regulated

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Seeking FDA implementation customer experience

  • 1.  Seeking FDA implementation customer experience

    GOLD CONTRIBUTOR
    Posted 22 days ago

    Hi AX Community!

     

    Our business is running AX 2012 RTM. We are mainly a distributor for our parent company in Japan. Some of the products we plan to sell in the upcoming years will be regulated as medical devices by the FDA. This is uncharted territory for our business.

    The products we are buying and selling that will be controlled by the FDA are mainly purchased from Japan, but there are some cables, computers, and other ancillary items that go with these devices that are ordered domestically that need to be collected into a 'kit' using a BOM from a production order. Then the 'kit' needs to be delivered and installed at the customer site.

    We recognize that part of the requirements for the FDA will include segregation of our medical FDA products from our non-FDA medical products in our system to reduce the scope of inspection by the FDA.

    I would like to discuss with an end-user of AX their experiences when going through this, and how they use their system to meet the requirements of the FDA. Look forward to any responses here. Thanks!



    ------------------------------
    Seth Greenberg
    Supply Chain Manager
    Hamamatsu Corporation
    Middlesex NJ
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  • 2.  RE: Seeking FDA implementation customer experience

    TOP CONTRIBUTOR
    Posted 15 days ago
    Edited by Robin Finnell 15 days ago
    Hi Seth-

    I am in Food Manufcturing, so our requirements are somewhat different than yours. I know we are using batch attributes to segregate products based on attributes of the products, such as age, style, color. Could you potentially use a batch attribute to segregate FDA from non-FDA? Just a thought. I hope another FDA Reg member has a better answer for you!

    RF

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    Robin Finnell
    Continuous Improvement Coordinator
    Operations Lead - D365FO/MES Implementation
    Tillamook County Creamery Association
    Tillamook
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  • 3.  RE: Seeking FDA implementation customer experience

    GOLD CONTRIBUTOR
    Posted 10 days ago
    Hi Robin,

    Thank you for your input! We will certainly consider that while testing. Look forward to more replies on this topic! (fingers crossed)

    ------------------------------
    Seth Greenberg
    Supply Chain Manager
    Hamamatsu Corporation
    Middlesex NJ
    ------------------------------



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