This site has moved to the integrated Appfire documentation and information site for our apps.

From February 2024 this site is no longer updated.

Take a look here! If you have any questions please email support@appfire.com

Skip to end of metadata
Go to start of metadata

You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 2 Next »

USE CASE

Use Comala Document Management workflows to reinforce your compliance policy and procedures

Automating the review and approval process to ensure that document review and approval is undertaken by the right people and changes are tracked and reported to meet requirements.

What are the ways teams benefit?

Compliance

Minimize the risk of errors by ensuring that documents are reviewed and approved by the correct people.

Track and report all changes and approvals, mandatory for meeting regulatory standards.

This protects your company from legal liability while strengthening its reputation

Knowledge Bases

Provide clear visibility into the documentation lifecycle status so knowledge workers see

  • which pages are approved

  • which are in progress

  • which pages need attention

This increases the accuracy of documentation and reduces the risk of misinformation.

Policies and procedures

Reduce the chance of accidents, compliance violations, and other problems by automating workflows to manage the lifecycle of your policies and procedures.

Set expiration dates so that you’re notified when it is time to review and update your processes.

This ensures that policies and procedures are up-to-date, consistent, and secure.

To get started

Compliance

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.

Different space publishing

Quality Management System workflow

Publishing the approved pages using Comala Publishing

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.

 

  • No labels