As the Admin, you are responsible for ensuring that 'change control' is established through Enzyme's Document Control module.
The Document Control Module stores all your company's documents and their change history.
The Approvals Module stores a history of your company’s approvals from across the application.
The Training Module manages your company’s training assignments and stores your training records. It also allows you to track training status to ensure your company is up to date.
Overview of Document Control Module
The Document Control Module allows you to view your company's documents. Companies establish “change control” through their Document Control Module by showing the changes, who requested them, who approved them, justifications for the change, and assessments.
It is a repository of controlled data that does not otherwise live in Design Control or Risk Management Modules (such as SOP’s).
As you develop your QMS, be sure to think about the document numbering and naming conventions you want to follow. We recommend using a convention that will allow you to easily organize and find documents in Enzyme's Document Control Module.
The convention built into the app is as follows:
[document type][number] [document name] [revision]
QSM001 Quality System Manual Part 1 Rev 0.1
The Document Control Module allows you to create document types (e.g. QSMs, SOPs, WIs, etc.) and automatically assign a revision based on the document lifecycle. Enzyme also allows you to number documents, either automatically or manually, to suit your needs.
We suggest using the document convention listed above. As document updates are approved, the revision number will be updated and tagged with the new date, so you will always have a full history of the document.
Admins (users who have the permission level of Quality Owner) and Approvers can manage folders in Enzyme.
At this time, if you aren't ready to set up the folder structure, you can add documents first and then create folders later.
Managing Document Types
Before adding documents to Enzyme, you need to create Document Types to keep them organized. Different document types can have approvers from different roles.
Once you have created document types, you can start uploading documents to Enzyme.
As we mentioned in the Intro to Admin Training course, Enzyme has a Document Library that contains samples for Standard Operating Procedures (SOP's), Work Instructions, Forms, etc. Reach out to us if you'd like access to these documents.
Creating New Documents
Once a document has been created, it can always be revised. The revised document will create a new draft and the document will have to be re-routed for approval for the changes to become effective.