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From February 2024 this site is no longer updated.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

Version 1 Next »

USE CASE

Summary intro text

What are the ways teams benefit?

Compliance

Comala Publishing together with 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 /wiki/spaces/CDMCD/pages/6969366578 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

E-signature in the QMS workflow

Both approvals in this workflow is to require users to use their email and a one-time password (OTP) to confirm their identity when registering an approval.

Approvals (content reviews) are disabled in the workflow popup until the email and a token are entered.

Reviewers are prompted to setup a personal code when they first visit a page in the content review state and access the workflow popup.

As a reviewer, to be able to electronically sign for Document Approvals you will need:

  • your mobile device with a 2 Factor Authentication (2FA) app.

  • your email address that you use to login to Confluence.

This setup only needs to be undertaken by a user once in each instance. However, the 2FA app tokens from the OTP provider are time-limited.

The global administrator can configure the app use for the OTP provider and, if required, mandate that all users using an e-signature reset their user approval tokens.

Different space publishing with Comala Document Management

Different-space publishing allows you

  • to edit draft pages in one space in a cloud site

  • then publish these pages to another space (in the same cloud site)

The Comala Publishing for Cloud app must be installed to enable different-space publishing.

/wiki/spaces/CPCD/pages/7468224603 can only be used to publish Confluence Cloud pages. Comala Publishing cannot publish bog posts.

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.

  • No labels