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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Prevent errors and compliance violations resulting from outdated information.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 The sync status informs users they are viewing the most current information or if there are unpublished changes.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

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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.

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Publishing the approved pages using Comala Publishing

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Compliance

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

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

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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 and the Comala Document Management Cloud app.

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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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