Enzyme is an online QMS that is designed to streamline your documentation and processes.

Here is a video on features available to admins. After reviewing the video and article, proceed to Setup Guide for Users to set your Enzyme account and settings.

Note: This video was created using V1.26.0. Enzyme is updated weekly so some elements may change.  

Enzyme Overview for Users

When you log in, you will see the Dashboard. The Dashboard provides a quick overview of the Pending Trainings, Signature Requests and general notifications. This at-a-glance view allows you to prioritize what is required first. 

Users can have various permission levels which vary the actions you can perform within Enzyme. These are: Viewer, Editor, Approver and Quality Owner.
 
Admins have the permission level of a Quality Owner and have a few additional functionalities available to them, learn more about them


In the Navigation bar you can access: 

  • The Product Menu: This menu is available in the Design Control and Risk Management modules. It allows you select your product and view its design and risk items. 
  • Enzyme Modules: These Enzyme modules store data about your product(s). 
  • User Settings: These settings allow you to update your profile, change your password, set a signature, or log out.
  • Support: The ? icon links you to this support center so you can search or find topics in which you are interested. 

Enzyme consists of eight modules:

Product

  • Design Control: This module stores design information about your product(s).
  • Risk Management: This module stores information about the risks your product(s) pose to your users. 
  • Document Control: This module stores information that must be controlled and does not fit in Design Control or Risk Management modules. It contains all Standard Operating Procedures (SOP’s) that describe what your quality system is supposed to do. 
  • Change Requests: This module stores information about all change requests for your product(s). 
  • Training: This module allows you to access the training you have to complete and view the trainings you have already completed. 
  • Suppliers: This module allows you to manage all your suppliers. 

Improvements

  • Audits: This module allows you to manage all your audits. 
  • Complaints: This module allows you to manage all complaints about your product(s).
  • Nonconformance: This module allows you to manage all nonconformances of your products(s). 
  • Corrective and Preventive Action: This module allows you to manage all the CAPA’s for your product(s). 

User Settings
The User Settings menu allows you to update your profile, set your signature and update your password. In Enzyme, Admins have the permission level of Quality Owner and have additional functionality in this menu.  

Secondary Navigation

The secondary menu allows further navigation.

Here you can 

  • Notifications: Receive notifications for items you have to review and approve such as change requests, and training you have to complete.
  • Product History: Shows all approved changes to the product with newest displayed first.
  • Export: Generate an export of your product’s Design History File. Generally, this function is only needed during audits or submissions to regulators.
  • Review: Available in the modules in the Product tab, you can initiate a Design Review. At least two design reviews should be performed before shipping a new iteration of any product. It should be done before final Verification & Validation testing begins and after Verification & Validation testing is complete.
  • Trace Matrix: Export the trace matrix for a product which can be selected in the Product Menu. The product menu is available in the Design, Risk and Design History modules.
  • Change Request: Create, save as draft, and submit a change request. A change request has to be submitted when you change design data or a document.

Product Menu

In the Design Control, Risk Management and Design History File modules, you’ll see the Product Menu in your navigation. If your company is working on several products, the product menu allows you to filter data for one particular product.

When you click on the product menu, you’ll see all the products your company is working on in Enzyme. Select or search for the product to see its specific design control, risk management data or Design History File data.

Next Steps

Read the Setup Guide for Users to set your Enzyme account and settings.  

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