The FDA and regulatory bodies require DHF files when submitting for approval. During an audit, the auditor also asks for a copy of the DHF.
There are three types of DHF available
- Design History for an Design Control category of a product
- Design History documents associated with a product
- Trace matrix for a product
Users with permission level of Quality Owner, Editor and Approver can export the design history of a category. In addition, Viewers can export the document history and trace matrix.
Note: This video was created using V1.26.0. Enzyme is updated weekly so some elements may change.
Design History Files
Access Design Control under Process in the Navbar.
Select the product for which you want to view the Design Control items and export the DHF.
Once you initiate an export, the DHF files will be emailed to you and also available in the app through the notifications.
DHF file for Design Control Categories of a product
For each Design Control category you can export the items of that category.
When you click on the export, you will be asked if you want to include draft and pending approvals.
To include them turn the toggle ON and then click Export. When the export is ready, you’ll see it in your notifications and email.
Design History File
From the Product menu, select the Design History file module. Here you will see all the documents associated with the product that has been selected in the product selector.
In the Document Control Module, in the Edit Metadata section, Quality Owners can associate documents to a product and also to a design phase. Design phased can be customized under Company Settings by the Quality Owner.
Click on the export icon.
Here you can either customize your DHF specific items and to include draft/pending items as well by turning the toggle ON.
The product's DHF file (by default) will contain:
- Change Log
- Design Outputs
- DHF Index Documents
- DHF Index Spreadsheet
- Trace Matrix
- User Needs
If you do not want some of these exported, turn the Customize DHF export ON. Then only select the items you want exported.
Once you have selected the items click Export. The DHF export will be emailed to you and available in your notifications.
From the Product menu, select the product in which you are interested. At any time you can click on the trace matrix icon in the secondary menu to quickly generate the trace matrix. This will include approved Design Control items.
When ready, it will be available through your notifications and emailed to you.
If you have any questions, you can reach us through the in app chat or email us at firstname.lastname@example.org.