SIG - FDA Regulated

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Seeking FDA implementation customer experience

  • 1.  Seeking FDA implementation customer experience

    GOLD CONTRIBUTOR
    Posted Jul 26, 2019 11:34 AM

    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!



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

    TOP CONTRIBUTOR
    Posted Aug 02, 2019 12:32 PM
    Edited by Robin Finnell Aug 02, 2019 12:32 PM
    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 Aug 06, 2019 04:53 PM
    Hi Robin,

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

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

    Posted 6 days ago
    Hi Seth,

    I'm not sure whether you're still looking for help. I'm with AXSource Infotech Inc. We are a MS Partner that sells Dynamics AX/365 and provides implementation and support services. Our sister company, AXSource Consulting Services Inc.  has been providing Regulatory and Compliance services to Pharma and Life Sciences organizations for 25+ years and they are very familiar with FDA requirements and are often called in to audit and/or validate ERP systems to ensure they meet GxP requirements … and I suspect that's the concern you'd like to address.

    I know someone from that team would be able to provide some guidance or at least point you in the right direction. If you send a message to info@axsource.com, we'll pick it up and get it to the right individual to help you.

    Best,

    Charlene
    416-697-8512


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    Charlene Smith
    Director, Sales & Marketing
    AXSource Global Pvt. Ltd.
    Oakville ON
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