Deviation Management

Deviation Management

A deviation is any abnormal event non-compliant with a standard or procedure. The EU guide to Good Manufacturing Practice (GMP) states that any deviation from the approved requirements and procedures must be documented and explained.

Deviations may occur accidentally (unplanned) or may be conducted to avoid certain circumstances (planned). QuaLIS provides comprehensive deviation management with a configurable workflow.

Deviation Management: Solution Highlights

  • Configurable workflow
  • Raising Deviation/ Incident from other application modules
  • Definable action plan with responsibility
  • Effectiveness of action plan & approval
  • Closure of Deviation/ Incident with review

Deviation Recording

  • Deviation Recording
  • Record Deviation details & affected area/ process
  • Record investigation details & action plan for risk mitigation
  • Effectiveness & review deviation details
  • Monitor deviation status & closure
  • Deviation & summary reports

Web-based solution can be accessed through any browser      

Key Benefits

  • Systematic workflow management & status updates – Configurable workflow
  • Record traceability and on-time follow up – Detailed investigation with effectiveness
  • Document Training details & attendance – Summary Reports

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