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?
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
Choose from the “out of the box” workflows, or create your own!
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.
set upE-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.
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)
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. |
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.
Disclaimer
Appfire does not claim compliance or certification of any of our tools. In addition to taking advantage of technical elements, compliant systems must implement procedural and administrative controls.