Created by potrace 1.16, written by Peter Selinger 2001-2019

Automated UDI Submissions

Helped submit more than 110,000+ products in 6 months to the FDA GUD-ID for a Fortune 500 Med Device Company

Business Challenge

  • To meet the guidelines stipulated in CFR21 Part 11 for Unique Device Identification (UDI) related to the medical device industry
  • Regulations required to capture and electronic transfer of basic information of a med device in the market to FDA’s Global Unique Device Identification database (GUDID)

The Solution

  • Design and deployed a common PLM Process for all PLM systems (Windchill, Agile, Master Control, SAP)
  • Develop a Hands-On-Table Java Based Multi-Edit Spreadsheet Functionality
  • Develop a Change Control Process that integrated with the Enterprise Change Control Process and ensured an Electronic Approval Process based on CFR21 Part 11 Guidelines.
  • Provide real-time updates to the users on the status of Data Packages in the Downstream Systems – ERP, MRP etc.

Benefits

  • The automated process and integrating the Enterprise Systems seamlessly, helped customer submit products easily to FDA GUDID Database in less time
  • Mass Data Edits for Catalog Parts using multi-edit spreadsheet functionality helped save 23% of end-users time
  • Closed Loop CM-II Certified Change Management Workflows for approvals as per CFR Part 11 helped streamline product design changes and reduce design rework time by 30%
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