Reinforce regulatory compliance initiatives

USE CASE

Automated document lifecycle management ensures that authorized users can review and approve documents. Adding an electronic signature layer protects content with encryption and authentication, safeguarding sensitive information. Additionally, Comala Document Management tracks workflow document activities to facilitate compliance with standards.

What are the ways teams benefit?

Reduce non-compliance risk and associated penalties by ensuring that documents are routed to the correct reviewers and approvers according to industry standards.

Provide accessible evidence of document approval and compliance by tracking all changes made to a document to 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 implement procedural and administrative controls.

For example, you can create electronic signatures and audit trails that provide document approval and compliance evidence. 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 FDA Title 21 CFR Part 11 compliance statement.

This compliance statement was originally designed for our Confluence server and data center apps. However, many 21 CFR Part 11 elements translate to Confluence Cloud with Comala Document Management solution (e-signatures).

Regarding the Atlassian Confluence Cloud environment, you will need a controlled environment and a working environment to help satisfy 21 CFR Part 11. To help meet this, we recommend using our Comala Publishing app and 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 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 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 editor for advanced authoring to create a more flexible and responsive workflow for your document process needs

Quality Management System workflow

set up

Publishing the approved pages using Comala Publishing

Different space publishing

Reporting

In-app tools track document activity

across a space using the Document Report
for an individual page using the Document Activity report

Add configurable page reporting macros to create custom dashboards for your teams

Customer case studies

Our customers 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.

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