Now that you have established the fundamentals of your QMS, you can begin documenting your premarket activities in Enzyme.

This includes:

  • Setting up Design Controls

  • Establishing Risk Management

  • Setting up your Design History File (DHF)

  • Managing your suppliers

We'll provide step by step guidance and examples of best practices.


Your Enzyme Instance

As you proceed through the course, you can log into your instance of Enzyme to complete the actions.

Your company's URL: [yourcompanyname]

Support Center

Access the comprehensive Support Center through the '?' in the navigation menu. The Support Center has step-by-step articles and videos on product features and modules.

Enzyme Training Environment

If needed, Enzyme can provide you with access to our training environment so you can try out some of the features explained in the course.

Training URL:

If you would like access, please ask your Enzyme Customer Service Rep for an account.


Reach us through the chat in your environment or email us at for any questions or feedback.

Next: Design Control Module

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