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Comala Document Control ISO 13485 Sections 4.2.4 & 4.2.5 (Control of Documents, Control of Records) Compliance Statement
1. Checklist against the ISO 13485:2016 requirements of sections 4.2.4 and 4.2.5 (Control of documents, control of records)
Reference | Gist | Comalatech apps | Confluence | Processes and activities |
4.2.4 (a) | Review and approve documents for adequacy prior to issue; | Comala Document Control provides a method of enforcing review and approval processes for documents using configurable workflows. This approval process is supported by built-in electronic signatures and an audit log. | Each Confluence page has a unique Space/Title combination. Page versions are captured automatically and provide comparisons between versions. Unique page identifier may be allocated manually (i.e., using page properties or page metadata). | Define the review and approval process which works best for you. |
4.2.4 (b) | Review, update as necessary and re-approve documents; | The approval process, as provided by Comala Document Control, supports 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 Control provides the means to clearly distinguish between current and draft versions of documents. | Confluence provides a complete history of changes to each document. If you setup a dedicated official space, then this feature will provide 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 document are clearly identified, and their distribution is controlled | Confluence provides a way to attach external files to pages; providing the sturucture to allign external documents with your internal structures (approvals, identification, access management) | ||
4.2.4 (g) | Prevent deterioration or loss of documents; | Implement 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 Control 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 backup mechanism. | |
4.2.5 |
| Confluence provides facilities to limit the access to documents in a granular manner. Confluence also keeps historic versions of pages and provides comparisons between page versions. |
2. Tips on how Confluence and Comala can reinforce ISO 13485:2016 processes
2.1 Annual reviews of documents
It is required to review all your QMS documents periodically. Comala Document Control 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 document. For example:
- Minutes of meeting form;
- Management review form;
- Clinical protocol;
- Quality plan
Confluence page templates are an excellent way to put all the forms at the hands of your team.
2.3 Medical Device Files (MDF) and other special collections (i.e DHF, FMR)
A Confluence page can be setup to be the index of your MDF, with hyperlinks to all the relevant pages and files (either attachments or external links) which are included in your MDF. This provides for 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.
2.4 Internal communicationÂ
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 who maintain their Quality Management System in Confluence :
Component | Role |
Confluence | The platform for creating, storing and using the documented information. |
Comala Document Control | A Comalatech app for Confluence which provides a way to enforce an approval process for documents using configurable workflows. This approval process is supported by built-in electronic signatures and an audit log. |
Secure infrastructure | Provide a secure platform, where only authorized users are accessing and modifying the data. Backup facilities. |