USE CASE
Automated document lifecycle management ensures that only authorized users can review and approve documents. By adding an electronic signature layer, content is protected with encryption and authentication, safeguarding sensitive information. Additionally, Comala Document Management tracks document activities to facilitate compliance with regulations.
What are the ways teams benefit?
Minimize the risk of errors by ensuring that documents are routed to the correct reviewers and approvers, according to industry standards.
Provide easy evidence of document approval and compliance by tracking all changes made to a document, so you can see who made the changes and when.
Efficient time-sensitive approvals keep everyone in the loop with automatic notifications when their attention is needed.
Compliance
Comala Document Management includes features that enable you to enforce compliance with industry standards and regulations.
In addition to taking advantage of technical elements, compliant systems must also implement the necessary procedural and administrative controls.
For example, you can create electronic signatures and audit trails that provide evidence of document approval and compliance. You can also set up automatic archiving and retention policies that ensure documents are stored and disposed of in accordance with regulatory requirements.
Information on how Comala Document Management can assist you with Part 11 compliance, is available in our compliance statement for FDA Title 21 CFR Part 11.
This compliance statement was originally designed for our Confluence server and data center apps. However, many of the elements for 21 CFR Part 11 translates to Confluence Cloud with Comala Document Management solution (e-signatures).
In regard to the Atlassian Confluence Cloud environment, you will need to have a controlled environment and a working environment to help satisfy 21 CFR Part 11. To help meet this we recommend the use of our Comala Publishing app together with the Comala Document Management Cloud app.
Once pages in a space have gone through the review and approval process provided by the Comala Document Management workflow, the Comala Publishing app can be used to automatically publish and sync the approved content to another target space for your published pages. In this published space, users will have view-only rights to the published pages.
To get started
install Comala Document Management by getting started on the Atlassian Marketplace or through “find new apps” in your Confluence instance
apply a workflow at across all documents in a space or apply workflows on a page-by-page basis
configure your workflow in the space settings Comala Document Management dashboard
edit and customize your workflow using the workflow builder visual workflow editor for advanced authoring to create a more flexible and responsive workflow for your document process needs
Choose from the “out of the box” workflows or create your own!
Different space publishing
Quality Management System workflow
/wiki/spaces/CAD/pages/7794952032 in the app!
Publishing the approved pages using Comala Publishing
Use cases
Customer case studies
We have a number of our customers who use Comala Document Management and Comala Publishing as part of their review and approval document and compliance process including helping to attain FDA Title 21 CFR Part 11 in the life sciences industry.
Disclaimer
Appfire does not claim compliance or certification of any of our tools. In addition to taking advantage of technical elements, compliant systems must also implement the necessary procedural and administrative controls.