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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Original Message:
Sent: Aug 06, 2019 04:52 PM
From: Seth Greenberg
Subject: Seeking FDA implementation customer experience
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
Original Message:
Sent: Aug 02, 2019 12:31 PM
From: Robin Finnell
Subject: Seeking FDA implementation customer experience
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
Original Message:
Sent: Jul 26, 2019 11:34 AM
From: Seth Greenberg
Subject: Seeking FDA implementation customer experience
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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