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titleUSE CASE

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What are the ways teams benefit?

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Mitigate non-compliance risk by maintaining accurate and current information that complies with required laws and regulations, avoiding fines, penalties, and legal actions. We suggest integrating with Comala Document Management to automate document maintenance and publishing.

Reduce the risk of data breaches and protect sensitive information by restricting access to authorized users and groups. Approved content will only be visible to those with permission.

Prevent errors and compliance violations resulting from outdated information. Quickly sync to the published space so authorized users have access to the latest version of a document. The sync status informs users they are viewing the most current information or if there are unpublished changes.

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Different space publishing with Comala Document Management

Comala Document Management automates the document lifecycle and approves pages in the Comala Document Management workflow to a final state. The final state page can be automatically published and synced to a different space using Comala Publishing.excerpt-include

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CDMC:Different - space publishing CDMC:Different-space publishingnamedifferentspacepublishing_desc_graphicnopaneltruelets you

  • edit draft pages in one space on a Confluence cloud site

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

This integration provides control over where and when the approved pages are published and manage the access separately to your draft pages.

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To get started

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An approval process workflow can be applied to the draft pages in the source space using one of the Appfire Comala Document Management family of apps - Comala Document Management; , Comala Document Control; , and Comala Document Approval.

Each of these apps supports the automated publishing of a source space page to the target space by Comala Publishing on the transition to the workflow final approved state in the Comala workflow applied to the page.

Publishing the approved pages using Comala Publishing

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Comala Publishing Cloud only publishes pages but cannot publish blog posts.

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Although the space home page cannot be published, the home page in each linked space can simply include Confluence page macros (children; page tree) to display the pages in that space.

Compliance

Comala Publishing together with and Comala Document Management includes include features that enable you to enforce compliance with industry standards and regulations.

  • Comala Publishing use can be integrated with Comala Document Management to deliver approved and up-to-date content to designated, centralized locations for permitted audiences. Comala Document Management provides an automated review and approval process for pages in your draft source space. Comala Publishing automatically publishes and syncs the approved pages to the target published space. As a result, collaboration can continue while preserving published versions.

  • Comala Document Management Cloud can create /wiki/spaces/CDMCD/pages/614010435 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.

In addition to taking advantage of technical elements, compliant systems must also implement the necessary procedural and administrative controls.

Info

Information Our compliance statement for FDA Title 21 CFR Part 11 provides information on how Comala Document Management and Comala Publishing 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 translate to Confluence Cloud with Comala Document Management solution (e-signatures).

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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 /wiki/spaces/CDMCD/pages/614008518 and the Comala Document Management Cloud app.

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Customer case studies

We have a number of our customers who use Comala Publishing and Comala Document Management 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.

 

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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.

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