Change Control Management

Change control is a systematic approach to managing all changes made to a product or system and is the most commonly executed processes within all MedTech organisations. Regulated companies are expected to maintain detailed documentation on all changes that are made in a change control software. Our intelligent workflow drives the complete process of controlled document management and enables all documented changes to be appropriately coordinated across all relevant departments. Software for change management can assist to assure compliance and significantly enhance a company’s productivity.


  • Designed to incorporate FDA and ISO 13485 best practices
  • 50% reduction in workflow time compared to paper-based systems
  • Workflow steps can be configured to suit your business requirements
  • Better leverage of existing resources

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