GHX will offer an industry solution that enables manufacturers to publish data to FDA’s Global UDI Database (GUDID) through a single connection that can meet a variety of needs, such as synchronizing data with business partners for e-commerce or other purposes. The GHX UDI solution will enable manufacturers to overcome technical challenges of publishing product data to the GUDID, while enabling them to gain incremental business value from their UDI investment.
The GHX UDI solution is designed to help manufacturers meet their FDA UDI compliance deadlines by supporting them through every step of this process, and comprising:
- GHX Business Solutions: Assisting manufacturers with developing a data governance model, establishing a process for capturing, validating and preparing product data, and identifying a staging solution
- GHX Health ConneXion Data Pool: A GS1 Global Data Synchronization Network (GDSN) compliant data pool that helps manufacturers synchronize product data with customers and business partners via a single channel
- GHX UDI Submission Service: This new GHX offering will enable manufacturers to submit Unique Device Identifiers and the associated attributes to the FDA GUDID in HL7 Structured Product Labeling (SPL) format and review FDA responses to those submissions.
The GHX Business Solutions UDI services and GHX Health ConneXion Data Pool are currently available to manufacturers, while the GHX UDI Submission Service is scheduled for launch in early 2014. (Source: GHX)