In Enzyme, you can create automatic templates that can be used to document items in the Design Control and Risk Management modules. Users with the permission level of Editor, Approver and Quality Owner have the ability to create document templates. The template documents can pull data from the Design Control and Risk Management modules.

If you’d like to create your own template document, please reach out to Enzyme support for a list of variables you can put into the template document. Once the template is drafted you can release it in Enzyme.

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

Create Custom Templates

Custom templates can be created in the Document Control Module which can be accessed under Process in the Navigation menu.

The process to create a template is:

Step 1: Create a Document

When creating or revising a document, turn the toggle ON to indicate that it is a Design Control module export template.

When the toggle is ON, this revision of the document will not be processed (i.e headers and footers will not be generated).

Step 2: Release document

Add the document to a change request and then submit Change Request with the document for approval. Once the document is approved and effective it can be associated with a product in the product menu.

Step 3: Associate with product (for Quality Owners)

Quality Owners have the ability to edit information about a product. The Product menu can be accessed from the Design Control, Risk Management and DHF modules under the Product tab. Click on the Edit icon for the product in which you are interested in the Product menu.

Here the Quality Owner can associate the document with the corresponding template.

Be sure to Save Changes when done.

Troubleshooting

If your template file is not getting the data you need, be sure the check the variables in your custom template document.

For example: If you hard core 'N/A' into a field then all your template exports will simply say 'N/A'. Instead add the variable associated with the field and if there is not data, then it will not be populated in the template export.

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

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