By Mike Kean,
As the President of a company that specializes in
Responses from Expert #1
1. Strict industry regulations.
2. Tracking leads/prospects.
Important to all industries, including Med Device. The fact that
3. Inventory control.
Med Devices companies must have traceablity/tracking for all products made. Microsoft Dynamics GP assists them keep in keeping track of materials from inventory to inprocess to finished goods.
4. Tracking quarantined items
Out of spec materials must be quarantined in the Med Device world. The ability to make separate locations and/or bins in Microsoft Dynamics GP is a huge benefit to segregating quarantined materials/products.
5. Inventory Control/Materials Planning
Microsoft Dynamics GP is an invaluable tool for knowing how much you have on hand and on order.
6. Reporting for Business Planning
Dynamics GP offers management reporting that allows you to budget as well as to see what is selling and what is not. It assists you in understanding what your cost drivers are by tracking all of the relevant information
Responses from Expert #2
As far as FDA reporting requirements and the whole regulatory environment, Microsoft Dynamics GP does a good job of tracking the necessary information.
2. Lot and serial number tracking
This is part of regulatory compliance but bears mentioning because it is one of the key elements of regulatory compliance. Microsoft Dynamics GP does handle lot and serial number tracking.
3. Component to parent/inheritance
This is also part of regulatory compliance. To comply with the FDA requirements, it is critical to track which components are used in which finished products. In the case of a recall, it is not enough to have data on the finished product only.
4. FDA approval process for new clinical trials
This is actually handled outside of GP, but because GP is built on a platform that allows for integration with most third party applications, this is also a benefit of Dynamics GP.
This is not important for regulatory compliance, but for implementing business practices that reduce waste, reduce costly inventory excesses, reduce back orders and ensure that the inventory on hand meets demand.
6. Intellectual Property (IP)
Medical Device companies frequently have to track the royalties due to the owner of the IP, i.e. the concepts or inventions that are being used in the products they manufacture. This is often a doctor, for example. Dynamics GP handles the tracking of IP royalties.