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UDI Solution

Xavor’s UDI Solution enables medical device companies to accelerate their product cycles by reducing the time needed to manage certain information sent to the FDA’s Global Unique Device Identification Database (GUDID).

UDI Solution

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UDI Solution

Introduction

With recent FDA compliance requirements for the unique device identification system (UDI), Xavor’s UDI Solution enables medical device companies to accelerate their product cycles by reducing the time needed to manage certain information sent to the FDA’s Global Unique Device Identification Database (GUDID).

Our Agile PLM UDI Solution:

  • Business Benefits & KPIs
  • Guides users while creating your Part/UDI number
  • Helps users enter large numbers of attribute data with a help screen to assist them
  • Electronically submits your UDI information to the FDA from Agile PLM

Capabilities

  • FDA Rule Management
  • Flexible solution to implement UDI FDA rules
  • Fast track implementation
  • Flexible solution to add/modify new FDA required fields
  • Create multiple templates to avoid data entry
  • Wizard based step-by-step approach to interact with user for data entry
  • Validation at each step to avoid any human errors
  • Revision management
  • Using Agile PLM for storing UDI data fields
  • Revision management of Finished goods and UDI documents
  • Bulk upload for migrating multiple UDIs at one time
  • Auto-Creation of UDI and Change Order and association with Finished Good parts
  • Auto transformation of HPL7 format
  • Direct Submission to FDA using ESG
  • Dashboards and Reports

Business Benefits & KPIs

  • FAST track solution to meet aggressive deadlines
  • Flexibility – to accommodate future FDA rules
  • Simplicity – interactive solution for data entry of 50+ fields
  • Improved Audit Readiness – to reduce Audit Risk
  • Decreases time and cost – to keep track of UDIs
  • Lower risk of human error – while submitting UDI to FDA
  • Less Training – interactive and user friendly solution

GUDID Submission

UDI Data Creation

Key Capabilities

  • Quick installation of wizard application for UDI data creation
  • Easy configuration of add/ modify fields and validation
  • Configure new/modify data dependencies
  • Templates
  • Agile PLM for persisting UDI fi elds
  • Agile PLM for revision management

Bulk import Key Benefits

  • Fast Track implementation
  • Less risk of human errors
  • Reduces time to bring UDI in system which increases cost & time efficiency
  • One database for storing UDI (Agile PLM)

Revision Management

Key Capabilities

  • Creating/maintaining multiple revisions in Agile
  • Workflow management & signoff

Key Benefits

  • Capturing all design changes for each revision
  • Capturing DMR information
  • CFR 21 part 11 compliance
  • Integrate product and UDI in Agile

Data Export & Review

Key Capabilities

  • Data Export to multiple FDA templates
  • Data transformation to XPL7
  • Dashboards and Reporting

Key Benefits

  • Data Export to different templates
  • Data Review before submission
  • Generating a XPL7 for submission
  • Dashboards and reports UDI tracking

FDA Submission

  • Key Capabilities
    • Direct UDI submission to FDA
    • Make dynamic changes before submission

    Key Benefits

    • Automatic submission
    • Seamless integration
    • Bulk submission