The eQMS is a digital system that allows you to create, manage, and track all your quality and regulatory documentation. It is a comprehensive tool that helps you manage your documentation from start to finish and makes sure you are complying with document control requirements.

A Quality Management System consists of two main elements which are covered in your success criteria:

  1. A document storage system for tracking document drafting, review, and approval
  2. Standard operating procedures (SOPs) that define how you build, test, sell, and monitor your device

The eQMS covers the first part of the Quality Management System. You can access the eQMS by clicking the “eQMS” icon in the left sidebar. Note that you must first select a device in the “Device Library” to see the menu item.

FormlyAI provides a complete, scalable solution that grows with your organization, offering more robust features than basic solutions while maintaining the ease of use you need