Comala Document Management ISO 13485:2016+A11:2021 Sections 4.2.4 and 4.2.5 (Control of Documents, Control of Records) Compliance Statement

Cloud Migration Resources

Planning a Cloud migration? These resources can help you get started:

Comala Document Management Cloud features – Review Cloud features and understand key differences between DC and Cloud.
Migration support from Appfire – Learn how we can help you migrate smoothly.

Comala Document Management ISO 13485:2016+A11:2021 Sections 4.2.4 and 4.2.5 (Control of Documents, Control of Records) Compliance Statement

Document Version

1.2

This article explains how compliance with sections 4.2.4 and 4.2.5 can be achieved when using Confluence with Comala Document Management. It also provides information about support for other elements of the standard and a list of the tools required for successful implementation.

Confluence is a wiki used to help teams collaborate and share knowledge efficiently. It acts as your document collaboration and repository as it keeps full track of what changed in each document, when, and by whom. Team members can create, share, and collaborate on content.

If your organization has an EN ISO 13485:2016+A11:2021 quality management system, you can use Confluence to meet many of its requirements.

Extending Confluence with Comala Document Management helps you meet the requirements related to the management and control of documents and records (sections 4.2.4 and 4.2.5).

EU MDR

By implementing ISO 13485, companies can demonstrate their commitment to quality and regulatory compliance, which in turn supports EU MDR (EU Medical Device Regulation and IVDR) compliance. While ISO 13485 is not mandatory for EU MDR compliance, it provides a robust framework that indirectly ensures compliance. The EU MDR requires additional documentation (stipulated in Annex II and Annex III of the EU MDR for the medical device technical file and the in vitro device technical file) and additional records of post-market surveillance and clinical evaluation.

If you are using an ISO 13485-compliant QMS, you should go through Annexes ZA or ZB as appropriate to determine which elements of the QMS need to be revised to comply with the MDR or IVDR requirements. However, the processes in place using ISO 13485 for creating, updating, and maintaining this documentation largely remain unchanged.

We recommend reviewing our complementary compliance statement for FDA CFR 21 part 11 together with this document.

Need Help?

Need help setting up Confluence and Comala Document Management for controlled documents?  Contact us.


1. Checklist against the ISO 13485:2016+A11:2021 requirements of sections 4.2.4 and 4.2.5 (Control of documents, control of records)

Reference

Essence

Appfire Comala apps

Confluence

Processes and activities

4.2.4 (a)

Review and approve documents for adequacy prior to issue;

Comala Document Management provides a method of enforcing review and approval processes for documents. Built-in electronic signatures and an audit log support this approval process. The flexibility provided by the Comala Document Management macro language enables configuring an approval process that reflects your defined documented approval processes and the different organizational roles you have.

Each Confluence page has a unique Space/Title combination.

Page versions are captured automatically, and comparisons between versions are provided.

Unique page identifiers may be allocated manually (i.e., using page properties or page metadata).

Define the review and approval process that works best for you.

4.2.4 (b)

Review, update as necessary, and re-approve documents;

The approval process, as provided by Comala Document Management, supports the processing of updates according to the defined approval process.





4.2.4 (c)

Ensure that the current revision status and changes to documents are identified;

Comala Document Management provides the means to clearly distinguish between current and draft versions of documents. Some organizations go further and use Comala Publishing to help separate between approved pages and pages that are still in the authoring and approval process. It creates a structure of an authoring space, where approved documents are automatically published into an official space.

Confluence provides a complete history of changes to each document. If you set up a dedicated official space, this feature will show the difference between official versions of the page.



4.2.4 (d)

Ensure that relevant versions of applicable documents are available at points of use;



Users can access Confluence throughout the internet (as per your network and security configuration) using any device.



4.2.4 (e)

Ensure that documents remain legible and readily identifiable;



Each Confluence page has a unique space/title combination.

Keeping your documents electronically ensures they are always legible.

4.2.4 (f)

External documents are clearly identified, and their distribution is controlled;



Confluence provides a way to attach external files to pages, providing the structure to align external documents with your internal structures (approvals, identification, access management)



4.2.4 (g)

Prevent deterioration or loss of documents;





Implement a backup mechanism.

4.2.4 overall

Changes to documents are reviewed and approved by appropriate functions in the organization;

The definition of the approval process in Comala Document Management supports a role-based approval and review process.





4.2.4 overall

Documents are retained for a defined retention period;



Confluence provides the mechanism to retain all pages, including their historical versions.

Implement a backup mechanism.

4.2.5

  1. Records are a specific type of document;

  2. Segregation and limited access to sensitive information;

  3. Changes to records are identifiable;



Confluence provides facilities to limit access to documents in a granular manner.

Confluence also keeps historical versions of pages and provides comparisons between page versions.

2. Tips on how Confluence and Comala can reinforce ISO 13485:2016+A11:2021 processes

2.1 Annual reviews of documents

All your Quality Management System documents are required to be reviewed periodically. Comala Document Management actually provides a built-in way to force documents to be re-approved after a set period (if they have not been reviewed during that time), hence ensuring no document is neglected in this review.

2.2 Forms and standardization of document layout can be implemented via Confluence templates

Many procedures are implemented via forms or a standardized layout of documents. For example:

  1. Minutes of meeting form

  2. Management review form

  3. Clinical protocol

  4. Quality plan

Confluence page templates are an excellent way to put all the forms in the hands of your team.

2.3 Medical Device Files (MDF) and other special collections (DHF, FMR)

A Confluence page can be set up as the index of your MDF, with hyperlinks to all the relevant pages and files (either attachments or external links) that are included in your MDF. This provides an easy way to ensure that the MDF always points to the current versions of documents and prevents the duplication of information. The actual content that goes into the MDF may be, at the same time, easily retrievable to your use in a hierarchy and location that makes sense to them.

Additional records will need to be maintained to meet the EU MDR requirements. For example, ISO 13485:2016+A11:2021 requires you to maintain a medical device file (clause 4.2.3), which has a minimum list of information to include. However, for the EU MDR, this documentation will need to include all of the information that is stipulated in Annex II and Annex III of the EU MDR for the medical device technical file. There is also an additional requirement for additional records of post-market surveillance and clinical evaluation. However, the processes you have in place for creating, updating, and maintaining this documentation will largely remain unchanged.

2.4 Internal communication 

Confluence is conducive to information sharing, internal collaboration, and communication.

3. The toolset required to set up a document management system on Confluence

The following table shows the typical set of tools used by companies that maintain their Quality Management System in Confluence :

Component

Role

Confluence

The platform for creating, storing, and using the documented information.

Comala Document Management

An Appfire Comala app for Confluence that provides a way to enforce an approval process for documents. Built-in electronic signatures and an audit log support this approval process. The flexibility provided by the Comala Document Management macro language enables configuring an approval process that reflects your defined documented approval processes and the different organizational roles you have.

Comala Publishing
(optional)

An Appfire Comala app for Confluence that helps separate between approved pages and pages that are still in the authoring and approval process. It creates a structure of an authoring space, where approved documents are automatically published into an official space. This helps ensure that document users always have access to the current approved release.

It complements the functionality of Comala Document Management but is optional. Some customers find it easier to work with a set of two spaces, or it can be used in cases where there are more strict auditing requirements.

Secure Infrastructure

Provide a secure platform where only authorized users can access and modify the data.

Backup facilities.

Find out more...

For more information, contact us

Or visit the Appfire website to find white papers, ebooks, app guides and documentation, and more in our compliance resource hub, including app feature resources that can help you put technical controls in place to protect company assets and comply with third-party data requirements (governmental or contractual)

The Appfire Trust Center also has the latest information on the security, privacy, and compliance of our products and services

 

(c) 2025 Appfire Comala Technology Solutions, Inc.











Need support? Create a request with our support team.

Copyright © 2005 - 2025 Appfire | All rights reserved.