SoftComply eQMS User Guide
Welcome to the SoftComply eQMS!
A Quality Management System (QMS) is a collection of procedures and processes which describe how your organization carries out the development, distribution and maintenance activities to comply with the applicable standards and regulations.
Having a compliant QMS is the basic requirement to enter the medical device market worldwide.
The SoftComply eQMS is a Quality Management System packaged as an add-on for Confluence Server. It is based on the requirements of ISO 13485:2016, IEC 62304:2006 (as amended in 2008 and 2015), ISO 14971:2012 and 21 CFR 820, making it applicable for both the EU and the US markets.
Benefits of using the SoftComply eQMS
1. Kick-starts your FDA and ISO-compliant Quality Management System development with ready-made and pre-filled SOPs and templates – all you need to do is add your company and product development details in them!
2. Your QMS is a designated Space in your company’s Confluence – home to all of your QMS related documents!
3. You can easily copy QMS templates from your QMS Space into other project spaces that your company manages and that need to comply with your Quality System requirements – quickly managing the QMS requirements in various projects you run!
4. The QMS Example Space provides a full exemplary QMS of a sample company – your guide to finalizing your own QMS documentation!
2. Quick User Guide
1. Install the SoftComply eQMS add-on from Atlassian Marketplace to your Confluence Server instance. You need Confluence administration permissions to do that.
2. After the successful installation, open the “Create Space” drop-down menu from the top navigation bar and create a new QMS Space.
3. The creation of the new QMS Space consists of these two simple steps:
3.1. Fill in Space Name, Space Key and the name of the Space editors;
3.2. Define Header and Footer content of all pages in the eQMS.
4. Customize the eQMS according to your Company’s business model, product and practices.
3. Setting up your QMS
3.1. Your Home to QMS – A space in your Confluence
1. Navigate to your Confluence homepage and create a new space
Figure 1 – Create QMS Space
2. Select “QMS Space” from the list of space blueprints to create your QMS space
Figure 2 – QMS Space Blueprint
3. Fill in the Space name and assign the appropriate QMS space editors. The assigned editors will inherit automatic Space Admin rights, although it is always possible to modify these permissions through the usual Confluence space settings.
These permissions can always be modified at a later stage using the standard Confluence user management.
Figure 3 – QMS Space Setup
4. Now you can insert the header and footer data that will show up on each page of your QMS manual, policy, SOPs and templates, i.e. company name and other specific details.
NOTE: Modifying headers and footers after this initial stage requires modifying each page separately! The bulk set up option shown below is available only during the initial setup of a space.
Figure 4 – Customize Headers and Footers of all your QMS documents
Figure 5 – Example of a header on a page of Quality Manual
Figure 6 – Example of a footer on a page of Quality Manual
5. The setup is complete! You have now created your company’s QMS space that contains the Quality Manual, the Quality Policy, 16 SOPs and 47 Templates. The Home Page of your QMS space provides you with a checklist for implementing the QMS throughout your company.
The ‘eQMS’ button brings you to the Home page of your QMS. The macro looks for the space in the category “qms_spaces”. This label should not be modified. The ’QMS Example Space’ has the “qms_example” flag and the ‘QMS Space (Trial mode)’ the “qms_spaces_trial” flag.
Figure 7 – QMS Homepage
The User Guide is a detailed look into each of the tasks in the checklist on your QMS Home Page that are required for setting up your QMS.
3.1.1. Customize your QMS
Several aspects of the eQMS must be tailored around your company’s activities and business model. Your QMS should reflect what your company does and should assist you in executing these processes in a compliant manner. It should not be viewed as a burden disconnected from the actual activities or a paper exercise!
In your QMS space documents you will have two types of text – normal text that is derived directly from the requirements of international standards, and the text in highlighted information-boxes that requires your attention and completion.
You should fill in this information based on the guidance described inside each box.
Figure 8 – Info boxes
Adding your company logo
Adding your company’s logo to the pages in your QMS gives you the opportunity to personalize the appearance of the QMS documents.
Adding and modifying you company logo is easy.
Just open and Edit the “Company Logo” page and replace the default logo with the one of your choice.
Adjust the size, position and other settings to optimize the appearance of your logo in your QMS pages.
Figure 9 – Company Logo Page
Figure 10 – Include Company Logo Macro Setup
This macro displays the logo or picture from a source page.
Figure 11 – Include Company Logo Macro
Adding your company name
Before setting up you Company’s QMS (as shown in Figure 4), all the documents have the company name as “ACME ltd” by default. This is just a placeholder and is replaced with the actual name of your company after the Setup of your QMS space.
Review the SOPs and Templates to ensure that the name appears correctly throughout!
Figure 12 – Company Name Setup
Some guidance in the eQMS is provided within attachments. For example, the two templates called “FMEA Template” and “Hazards Analysis Template”. These contain links from where the two excel files must be downloaded from, as Confluence does not currently support attachments in Space Blueprints.
Follow the directions in each information box; first download the files and then attach them to the page, so that the content will be displayed correctly.
Figure 13 – Download external Excel files
The rendering macro error is displayed because the macro won’t find the file to display until it is attached to the page. Once attached, the page will display the tables correctly.
Figure 14 – Link the Excel file in the macro
Figure 15 – Final Layout, table displayed
Adding functions and responsibilities
In several QMS documents it is required by regulations to list responsibilities for specific activities. These responsibilities are particularly important for the SOPs of your QMS. The person, or role, assigned with a specific responsibility must ensure that his/her owned procedures are maintained and correctly implemented within the company.
Figure 16 – Responsibilities
The assignment of responsibilities depends on the structure and business model of your company.
Tailoring your company’s Quality Policy
The Quality Policy is a brief statement of how your company will ensure that the Quality System is effective. The Quality Policy in the QMS Example Space is a good guidance on how to tailor this document.
Tailoring your company’s Quality Manual
The Quality Manual is an overview of the Quality System, highlighting how your company is going to comply with the applicable standards.
It also contains the structure of the QMS, the company’s organizational structure and the description of the Management.
The Quality Manual in the QMS Example Space provides a good guidance on how to tailor this document.
Tailoring the content of your company’s SOPs
Most SOPs require specific content to be filled in around your company’s practices and business model. The QMS Example Space provides good guidance on how to tailor these SOPs.
Should you require additional assistance or support in managing the content of the QMS, do not hesitate to contact us at email@example.com.
4. Rolling Out your QMS
Once you have completed the customization of your QMS, it’s time to release it throughout your company.
To manage documents’ change control, fill in the Change History table for each SOP, Template, Quality Manual and Quality Policy.
Note: Only the Template Change History must be populated at this time. It is accessible in the footer of each page in the Expand box.
Figure 17 – Roll Out
Follow your Document Control SOP to release the QMS.
Use handwritten signatures or an electronic signature system.
Training your company on QMS
All employees must be trained on the basics of your company’s QMS which includes the Quality Policy and the Quality Manual.
In addition, each employee must be trained on the specific aspects of the Quality System that he or she is responsible for or is going to use.
Each project or product should have its own Confluence space to manage the project related documentation.
A typical project space layout may be like the following:
1. My Test Project (Space)
1.1. Design History File.
– Phase 1
– Phase 2
– Phase 3
– Phase 4
– Phase 5
– Phase 6
Each Phase will have the applicable documents listed as children (e.g. Device Lifecycle SOP).
In addition, it will be necessary to create other support spaces to house specific types of documents.
Typically they are the following: CAPA; Audits; Change Requests; Records (e.g. Supplier List, Equipment List, etc.); Training; Post Market Surveillance.
Each QMS template can be used for a specific scope or project by clicking on the “Copy Page” button at the top of the template.
Insert the target space name and parent page, then click OK, and Confluence will bring you to the edit mode of the copied page in the target space.
With this button you can copy read-only pages from read-only spaces.
Figure 18 – Copy Page Button
Figure 19 – Deploying Templates
5. Your guide to customization
1. The Example QMS included in the SoftComply add-on is a filled in, complete QMS. The purpose of the Example QMS Space is to provide guidance on how SOPs and Templates can be tailored. In other words, it can guide you in the customization of your own QMS space by providing an actual case of a working QMS.
2. Proceed in the same manner as the QMS space, but select instead “Example QMS Space”
Figure 20 – QMS Example Space
This will generate a fully deployed QMS space with filled in content.
Note that data and details present in this QMS example are not taken from actual or proprietary documents.
6. Admin Guide
Administer your QMS documents by managing Confluence space permissions. The Atlassian Confluence documentation provides useful information on permission management in Confluence.
You will have to determine which documents should be visible or editable by any user and which ones should be locked or hidden. Follow the Atlassian guidelines to manage your space access permissions.
Only users with Confluence Administrator privileges can create new QMS spaces. “Create Space” permissions are not sufficient to perform this operation.
|Create QMS Space||Confluence Administrator|
|Create Example QMS Space||Confluence Administrator|
|Edit QMS Pages||Edit permissions on the QMS space|
|Copy Templates||Add Page permissions on the target space|
7. Installation Guide
The SoftComply eQMS is a Confluence add-on and can be installed via the Atlassian Marketplace. You need to have your Confluence administration permissions to be able to install it. If you don’t, contact your local Confluence administrator.
You can also access the Atlassian Marketplace inside your Confluence instance under Confluence Administration Add-ons section. Use search under “Find new add-ons” to find the SoftComply eQMS.
Why are some SOPs and Templates empty?
The Trial version of the SoftComply eQMS contains the full structure of a QMS, but not all content is available in the Trial mode. You can access the entire content of the eQMS by purchasing the full license.
What happens when my evaluation period ends?
When your evaluation period ends and you did not purchase the license, the SoftComply eQMS’ functionality will stop working. Any Trial space deployed during the evaluation will still be available but it will not be possible to create any additional Trial QMS spaces and the macros will not be working.
What happens if I decide not to renew the license?
Any QMS space that you have already deployed will not be affected, but it will not be possible to create any additional QMS spaces and the macros will stop working.
If you choose to purchase the license, all features will become available again.
What standards is the SoftComply eQMS based on and where can I find them?
I need help to customize my eQMS!
Visit the SoftComply website and get in touch with us. We will be happy to support you! Contact us at firstname.lastname@example.org
We also have an extensive network of consultants who can provide dedicated and professional support.