To market your product in the US and EU, the FDA and EU regulators require companies to establish procedures for audits.
There are three kinds of audits:
Note: This video was created using V1.24.2. Enzyme is updated weekly so some elements may change.
Overview of Audits Module
The Audits module can be accessed under Improvements from the navigation menu.
The Audits module allows you to document multiple kinds of audits within Enzyme, upload corresponding attachments and submit them for approval.
In the module, you will see all of the audits(Internal, External, Supplier) that have been documented in Enzyme. You will see the Audit ID, Type, major and minor non-conformances. Selecting the Columns button allows you to sort the column headings you want to view. Selecting the Add Filter button allows you to view only data pertaining to your filter(s).
Hover over and click on the audit you want to view to open it. You will see all the information pertaining to the audit and its status.
If the Audit is still open, users with the permission level of Quality Owners, Editors and Approvers can make edits. Once the edits are complete- you must route the audit for approval.
If an audit is closed, they can click on the Edit button to reopen it. Once the changes are made, it must be routed for approval again.
At any time - you can export all the audit records from the module.
If you have any questions, you can reach us through the in-app chat or email us at firstname.lastname@example.org.