The Design Control module ensures that the product meets user-defined needs, company-defined specifications, and fulfills their intended uses. FDA wants to make sure that your company has a plan for the design process and is following it. 

Design Control module can be accessed under the Product tab. 

The Design Control module is divided into 5 categories: 

  • User Needs: Voice of the customer (design inputs)
  • Requirements: Technical instructions for the engineering team (design inputs)
  • Design Outputs: Code, manufacturing specifications, drawings, diagrams components of your design. 
  • Verifications: Confirm you built what you intended with product tests that are conducted automatically, with external equipment and test engineers. 
  • Validations: Confirm you built what your users need by clinical trials or simulated “human factors” test. 

In each category you can:

  • View the change history of that Category 
  • Export all the data for that category. The content will be emailed to you and available for download for 24 hours. Alternatively you can click on the pop-up to view it. 
  • Create a new Design Control Card (all users except Viewers)

You will also see the info icon, which gives you more information and examples on the category. 

If you have any questions, you can reach us through the chat or email us at support@enzyme.com.

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