Is it Possible to Add Additional Product Data to What is Available Via the GUDID?

Yes, after getting UDI Connect into your Salesforce Org, go to the AppExchange and bring down the desired package. Once this happens, it is possible to add any field, pick lists, and look-ups from the Global UDI Database (GUDID) to the app. The app is highly customizable as USDM does not limiting like other managed packages. The application is flexible and designed in this way because USDM understands that all clients have different processes and practices as well as different intended uses for the application.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM's assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

Do Systems Need to be Updated in Order to Handle New Quantities and What Best Practices Does USDM Believe Will Emerge?

Jean Sargent, Vice President of Healthcare Strategy and Implementation at USDM Life Sciences, has been speaking with numerous solutions providers in order to understand where they are in relation to capabilities to transact with the UDI data. From the perspective of the supply chain, most of the large supply chain solution providers already have the capabilities to handle the capabilities built into their systems. If this capability is not on a built in version, solution providers have determined a path that allows the utilization of this information using subfields. When there is an upgrade all of the information will be in the correct fields and this information can then be used for transactions.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.

Is an Immediate Wave of Product Labeling Changes from all Manufacturers Expected?

It has been over a year since the Food and Drug Administration (FDA) required that class III devices were to be labeled with Unique Device Identification (UDI). Despite the common sentiment that labeling regulation can cause a great deal of reorganization and work, the packaging label is valuable. If you already have a packaging string built into your Item Master, you simply associate each UDI with that packaging string. The UDI for a 4by4 will have a different number for the package, box, and case. Use of this information within the Item Master ensures orders will transact utilizing the correct UDI with the associated product.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.