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, CDM tracks document activities to facilitate compliance with standards.

What are the ways teams benefit?

Compliance

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

 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.

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

The Quality Management Systems Workflow is bundled with the app and is a compliance review focussed workflow that has four states.

• documents start in Draft

  • transition to In Approval 

  • then transition to Approved

• a fourth state Obsolete is used to indicate that the document is retired - no new versions are expected

This workflow uses an e-signature process (user email and one-time password authorization) for each approval.

Users or group of users that are allowed to approve the In Approval state content are restricted

• this list of users is configured at space level by the space administrators

• the users as added as a value for a workflow parameter

• the workflow will assign the workflow parameter value as reviewers for the approval.

Assigned reviewers receive an email notification on the workflow transition to the In Approval state.

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.

Publishing the approved pages using Comala Publishing

Different space publishing

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)

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.

• TwelveSec

• Neurotrack