Comalatech Apps

Confluence

Processes and activities

7.5.1

Certain documented information is required

QMS documentation is maintained in one or several Confluence spaces.

Create the required documents natively within Confluence, or attach external documents.

7.5.2

Documented information should be:

1. Identified and described
2. Reviewed and approved

Comala Document Management provides a way to enforce a review and approval process for documents. This approval process is supported by built-in electronic signatures and an audit log. The flexibility provided by the Comala Document Management macro language enables configuring an approval process which 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 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.

7.5.3.1

Documented information will be:

1. Available to users;
2. Protected (from loss, misuse)

Comala Document Management provides the means to clearly distinguish between current and draft versions of documents. Some organizations go further and are using Comala Publishing to help separate between approved pages and pages which 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.

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

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

Use Confluence within a secure infrastructure. Implement policies for access management.

7.5.3.2

1. Users need to be able to access and use the documentation;
2. Documents need to be preserved; and dispositioned
3. Apply change control;
4. Certain external documentation should also be controlled

• Comala Document Management provides the mechanism to change control each document (see explanation for 7.5.2 above).
• For external documents: they can be attached to Confluence pages, and these pages then provide the control mechanism for the external document. Comala Document Management can then be used to approve each external document in a similar way to that of internal documents.

• Confluence permission mechanism is granular enough to allow some users to have 'view only' access to documents.
• Documents may be disposed by moving to a segregated area in Confluence (typically a space sub tree which is hidden from most users)

Implement backup policies.

Block Confluence pages from being deleted (through access management).

Confluence

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

Comala Document Management

A Comalatech app for Confluence which provides a way to enforce an approval process for documents. This approval process is supported by built-in electronic signatures and an audit log. The flexibility provided by the Comala Document Management macro language enables configuring an approval process which reflects your defined documented approval processes and the different organizational roles you have.

Comala Publishing

(optional)

A Comalatech app for Confluence which helps separate between approved pages and pages which 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 end users of documents will always access the current approved release.

It complements the functionality of Comala Document Management and 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 are accessing and modifying the data.

Backup facilities.