A company's Standard Operating Procedures (SOP's) are the building blocks of a Quality Management System (QMS).
SOP’s define business processes from ho a company is managing training to handling suppliers. The SOP’s should reflect how the business processes have been implemented.
Enzyme provides templates of the SOP's which a company can customize to match their business.
These SOP’s should be approved and effective in Enzyme. If you make a change to any of your procedures, the changes should be submitted for approval through a Change Request in Enzyme. This ensures the most current process are effective.
Accessing SOP's in Enzyme
Users with the permission level of Quality Owner can access the SOP's templates within Enzyme.
Click on your user settings and scroll down to Document Library.
Here you will see Enzyme's SOP templates for Hardware/software/In vitro devices and Software as a Medical device (SaMD). Click on the tab that matches your product type.
The Download button, allows you to download all the SOP and associated documents and forms.
You can customize these forms as needed. Once you are done a draft, upload it into the Document Control module as a new document. When ready, route it for approval.
If you have any questions, you can reach us through the chat or email us at firstname.lastname@example.org.