Software Validation

We help you demonstrate
your software is compliant with specifications and regulations.

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 and Validation
  • FDA Title 21 CFR part 11 compliance

Key Skills

  • 10+ years experience
  • GxP approach
  • COTS software validation
  • Spreadsheet macros validation
  • Custom software validation
  • Safety features testing
  • Integration with your quality management system (QMS)
  • Traceability Matrix of the requirements

Experience

  • Regulatory Compliance (IEC 62304)
  • ERP Validation
  • Validation of Software for Manufacturing Processes
  • Medical Devices Software