Unique Device Identification - UDI
UDI.Net is a software program that was created in order to provide a one-stop solution to meet the requirements of the FDA’s UDI-system. The acronym UDI stands for the “Unique Device Identification” system of the US-American FDA. Applied in the medical technology sector, UDI serves as a uniform labelling system for medical devices that brings together the most important product and manufacturer information and displays said information in shape of a code. This system is, however, not limited to the correct labelling on the product and packaging, but in fact includes the consolidation of all medical device information in a central FDA database.
Secure Supply Chain
The key aspects of UDI are governed via the FDA’s 21 CFR Part 830 and the topic is also addressed in chapter 7.5.8 of ISO 13485:2016. Implementing such a standardized product labelling system makes perfect sense, as it yields benefits for the entire supply chain ranging from the initial manufacturer via logistics right to the recipient. And, of course, the patient also benefits from the system, as the precise origin and properties of the medical device that were used in his case can be easily retraced via the UDI-code. The uniform UDI-system, moreover, simplifies product recalls, improves market monitoring, and eventually facilitates a secure supply chain all the way from the manufacturer to the customer.
GUDID - Global Unique Device Identification Database
UDI.Net was created in order to provide a one-stop solution to meet the requirements of the FDA. It is a software module that can either be operated standalone or in conjunction with other CAQ.Net®-modules. With UDI.Net, all UDI-relevant data is managed right at the master article record. This means that the information is always available in shape of an attribute and can be transferred directly to the FDA’s GUDID database. The software manages and tracks all procedures and reports that occur during the correspondence with the FDA, thereby allowing you to always have an overview of your data-transferal statuses and the status of each individual report. The UDI-specific libraries and lists that are contained in the software assist in preventing erroneous reports. All information is versioned in UDI.Net, thus increasing verifiability and clarity.
Because the software permits the automated transfer of data to the GUDID, it reduces the risks involved in the manual usage of the UDI-system and improves overall process efficiency. As UDI.Net can also be directly connected to e.g. an ERP-system via the Connect.Net module, there is also no need to maintain data in more than one software program.