The Design Control Module documents the way in which your product meets user-defined needs, company-defined needs, and how the device fulfills its intended uses. The FDA ( and notified bodies) want to make sure that your company has a plan for the design process and is following it.
Note: This video was created using V1.25.15. Enzyme is updated weekly so some elements may change.
Design Control Overview
Design Control module can be accessed under the Product tab.
The Design Control module is divided into 5 categories:
- User Needs express the user's (physician, clinical staff and patients) desires and needs for the product.
- Requirements are the features of the product that shall be implemented to meet the user needs
- Design Outputs are the products of your design process (drawings, specifications, software builds etc.)
- Verifications are the protocols used to test your product or otherwise confirm that the requirements are met as well as the reports that provide evidence that the requirements were satisfied
- Validations are the protocols and reports that demonstrate that your user needs are met and document. This includes the clinical trials, human factors testing etc. that are used to assess the product.
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.
The title of each column can be customized by the Admin (quality owner) in the Design Control tab in Company Settings. Also they can customize the product code from the Product Menu that will be displayed in each column. This can help differentiate items when they are exported.
Submit Design Control Cards for Approvals
Once the design control cards have been created, they must be added to a change request for approval. On the change request, the approvers listed will be based on the settings determined by the Quality Owner.
When the Design Control card is pending approval, it will have the 'Pending Approval' tag.
Once the change request is approved, the tag will be removed.
Once a design control card is approved, any changes to the title or description will return it to the draft state and it will have to be routed for approval again.
If you have any questions, you can reach us through the in-app chat or email us at firstname.lastname@example.org.