Reinforce regulatory compliance initiatives
- Robert Alexander Marshall
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 following 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 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 have gone through the review and approval process provided by the Comala Document Management workflow, the Comala Publishing Cloud app can automatically publish and sync the approved content to a target space for your published pages. In support of compliance needs, users can be configured to have view-only rights to the approved published pages in the target space.
Regulatory compliance-driven workflow
The Regulatory compliance-driven workflow ensures regulatory compliance by managing documents through a controlled process, making it ideal for compliance-sensitive environments.
It offers flexibility in reviewer assignments, reminder periods, and expiration timelines.
Documents progress through the following states:
Draft
1st Review
2nd Review
Approved
Rejected
Obsolete
Stakeholders (such as team members or managers) can be configured in each space to review documents. They can approve these documents using secure OTP (One-Time Password) e-signatures to ensure authenticity and compliance.
Automated reminders are triggered if reviews exceed set intervals. Approved documents expire after a default period.
If the Appfire Comala Publishing app is configured, approved documents are automatically published to the target space.
You can also use the Onboarding Get Started feature to apply the introductory Get Started - Quick Approval workflow to explore the review and approval of a document using a Comala Document Management workflow.
Reporting
In-app tools track workflow document activity on pages with an applied workflow
across pages in a space using the Document Report
for an individual page using the Document Activity report
Configurable page reporting macros can be added to pages to create custom dashboards for your teams
Appfire blog
Check out customer stories, resources, and case studies in the Appfire blog: