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Objective

Manage and support:

  • handling of exceptions, incl. deviations, complaints, audit findings, etc.
  • registration and monitoring of corrective and preventive actions

in accordance with GxP regulations  

Main functionality

  • Configurable workflows per exception type (deviation, complaint, audit finding, etc.), incl. steps like:
    - Initiation, incl. specification of affected product / process / object
    - Risk Assessment
    - Root Cause Investigation
    - Proposed Mitigation Actions (corrective and preventive)
    - Results of Mitigation Actions
    - Closure
  • Content and document management
  • Configurable roles and rights
  • User interface depending on roles and rights
  • Notifications and alerts (incl. escalation) by e-mail
  • Integration with RC-Change possible for linking of actions to Change Requests
  • Management Reporting

Advantages

  • GxP compliant exception handling and CAPA
  • Centrally and readily retrievable exceptions and CAPAs
  • Consistent exception handling and CAPA processes through standardization of approach, documentation and content
  • Efficient review and approval through automated workflow
  • Paperless compliance
  • Traceability of all open and closed activities
  • 21 CFR part 11 and Eudralex Annex 11 ready

The product flyer can be downloaded here.