After your product is on the market, you must start documenting post-market activities in your QMS.

Audits Module

The Audits Module allows you to document all of your audits in Enzyme. There are three kinds of audits that can be documented in Enzyme.

  1. Internal

  2. Supplier

  3. External

Here's an overview of the Audits Module.

Managing Audits

Start by creating an audit record in Enzyme.

Submitting an Audit Record for Approval

When all the audit information is complete, route the record for approval. If you edit an approved Audit record, it returns to the draft state and will have to be rerouted for approval.

Complaints Module

The Complaints Module allows you to document all the complaints received for your product(s). You can triage the complaints and take appropriate action.‍

Managing Complaints

Start by creating a new complaint record. Then when you are ready, route the complaint record for approval. To edit to an approved complaint record, you must first re-open it.

Next: Managing Nonconformances & NC/CAPA Settings

Did this answer your question?