In Enzyme, users with permission level of a Quality Owner can manage document types.
Some examples are:
- Quality System Manual (QSM)
These are high level documents that describe your organization’s approach and commitment to quality. Once customized, these can be released as the QSM document type.
- Standard Operating Procedures (SOP)
These documents describe the processes by which your company executes specific functions. Your SOPs must comply with applicable regulatory standards, and your operations must comply to your SOPs.
- Forms and Templates
You can create forms and templates that are associated with parent document, usually an SOP. For example: SOP001 Management Review is an SOP that requires some forms for compliance. Instead of releasing a standalone document, you can release forms as subdocuments, for example, SOP001-F1, SOP001-F2, and SOP001-F3. These forms and templates must be the first be released in Enzyme with the associated parent document (SOP001). Once released, and you use the forms and templates, and submit them to Enzyme as records (as a new document type!)
- Work Instructions
Work instructions provide implementation details for associated SOPs. They can be released as the WI document type. For example: WI002 Personnel and Training Work Instruction can be released to provide guidance on complying to SOP002.
When you fill out a form or a template, you are creating a record. These records should be released as a new document type (not as up-revs to the template) For example: a PLN type might be used to release planning documents like risk management or product development plans, a RVW type might be used for review meeting minute records, DHF type might be used for general design documents, BUS type might be used for business documents, etc. The important thing is that each record you create should be based on the latest released version of the template.
Other common documents types that are used by many companies within their quality management systems are listed below. These are not prescriptive; companies define them however they see fit. For additional examples of document types, please email us at firstname.lastname@example.org.
To view document list types that have been created in Enzyme, click on Doc Control Settings in the User Settings Menu.
You will then be able to see all the document types that have been created and manage them (edit/delete) as needed.
If you have any questions, you can reach us through the in-app chat or email us at email@example.com.