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Objective

Control and support the change control process, in accordance with GxP regulations.

Main functionality

  • Definition of change types and configurable workflow per type
  • Handling and registration of Change Requests
  • Configurable overviews on changes
  • Advanced search functionality
  • Management Reporting

Advantages

  • GxP compliant change control
  • Centrally and readily retrievable changes
  • Paperless compliance
  • 21 CFR Part 11 and Eudralex Annex 11 ready