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
- 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)
- 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.
- 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%