Be sureyour software worksas intended

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
  • Regulatory Compliance (IEC 62304)
  • Software URS
  • Software specifications
  • Software risk analysis
  • Software verification and validation
  • FDA Title 21 CFR par t 11 compliance
  • GxP approach
  • COTS software validation
  • Spreadsheet macros validation
  • Custom software validation
  • Traceability matrix of the requirements
  • Safety features testing
  • Integration with customer quality management system (QMS)


  • ERP validation (Priority, Mago, Business Central, BPCS...)
  • Asset Management Software (, EAM, …)
  • Minitab software validation
  • Validation of software for manufacturing processes
  • Labelling software (NiceLabel)
  • Minitab software validation

Discoverother services

Discoverwho we are