Creado por potrace 1.16, escrito por Peter Selinger 2001-2019

Envíos UDI automatizados

Ayudó a enviar más de 110,000 productos en 6 meses a la ID de la FDA de la FDA para una compañía de dispositivos Fortune 500 Med

Desafío de negocio

  • 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)

La solución

  • 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.

Beneficios

  • 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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