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Enzyme is a comprehensive Quality Management System (QMS) software that is designed to meet the requirements of cGMP, the QSR, and ISO standards throughout the product development lifecycle.

With its 21 CFR Part 11 compliance, out-of-box validation, and a wide range of integrations, Enzyme QMS provides an innovative solution for the life sciences industry, empowering medical device, digital health, and biopharma companies to effectively manage their quality and regulatory processes.

With Enzyme, you can easily import and integrate data from your existing tools, generate reports, and adapt the system to your workflows.


  • Covering key components of cGMP, QSR, and ISO standards
  • Support for the full product development lifecycle
  • 21 CFR Part 11 compliance
  • Out-of-box validation
  • Industry-leading integrations
  • Data import and integration with existing tools
  • Report generation
  • System adaptability to your workflows

Use Cases

  • Managing quality and regulatory processes in medical device, digital health, and biopharma companies
  • Supporting all stages of the product development lifecycle

Suited For

  • Medical device companies
  • Digital health companies
  • Biopharma companies

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