Software Validation

We help you demonstrate
your software is compliant with specifications.

Validation is a must to assure your software works as expected, compliantly and safely.

Our Capabilities

  • GAMP 5 approach
  • Software URS
  • Software Specifications
  • Software Risk Analysis
  • Software Verification
  • Validation Report

Key Skills

  • 10+ years experience
  • GxP approach
  • Black Box approach
  • Safety features testing
  • Integration with your quality management system (QMS)
  • Traceability Matrix of the requirements

Experience

  • Regulatory Compliance (ISO 62304)
  • ERP Validation
  • Custom equipment software validation
  • Validation of Medical Devices