San Francisco, CA (September 23, 2020)
Innovit, a global software company specialising in UDI compliance, Global Data Synchronisation (GDSN), Master Data Management (MDM) and Product Information Management (PIM) solutions, has announced today that B. Braun Medical Inc. (B. Braun) initiated its EUDAMED data submission project using Innovit’s UDI solution. This comes after the team’s successful replacement of its former GUDID solution in 2019 with Innovit’s UDI Connector for GUDID, which enables the direct submission of product data to the FDA.
Prior to using Innovit’s UDI Connector, B. Braun submitted their regulatory product data to the FDA via a GDSN data pool using Innovit’s GDSN Connector. Now using Innovit’s UDI Connector for GUDID, B. Braun can improve data alignment processes with the FDA and enable near real‑time data submissions to the GUDID. B. Braun also anticipates reducing overall costs by:
- eliminating the many system validations for GAMP5 compliance as a result of frequent GDSN upgrades.
- removing the fees for data pool subscriptions.
“Historically, there have been several upgrades to GDSN standards per year that require data pools to upgrade their system. This results in additional system validation work, which adds significant costs per validation event. Working with Innovit means we can avoid those costs by connecting and submitting data directly to the FDA,” said Gaurav Rai, Associate Director, Central Product Data Management at B. Braun.
“We were so pleased to team with B. Braun to deliver a solution that not only provides significant cost savings but also enables their Central Master Data Management team to improve compliance performance,” said Jesha Sauer, Strategic Accounts Executive. “We look forward to continuing our partnership with B. Braun for future UDI projects.”
Innovit’s globally certified product data management solutions protect revenue streams, reduce supply chain costs, improve online product marketing effectiveness and ensure regulatory compliance for Life Science, Healthcare, Food and Beverage organisations. Delivering a complete solution for master data management, with preconfigured modules that have out-of‑the-box data validation, and the broadest coverage for Global Data Synchronisation (GDSN) and UDI compliance to any market in the world.
Operating since 2000, Innovit is based in San Francisco CA with offices in London, Sydney and Melbourne and customers such as Johnson & Johnson, 3M, B. Braun, Bio-Rad, Southern Cross Hospitals, Kellogg’s, and Colgate Palmolive across diverse industries including Healthcare and Consumer products.
About B. Braun
Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pennsylvania and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, explore our website.