Table of contents
  • 1. INTRODUCTION
  • 2. QUICK USER GUIDE
    • 2.1. For Confluence Server and Data Center
    • 2.2. For Confluence Cloud
  • 3. SET UP YOUR QMS
  • 4. CUSTOMISE YOUR QMS
  • 5. ROLL OUT YOUR QMS
  • 6. GUIDE TO CUSTOMISATION
  • 7. BOOK A DEMO
SoftComply eQMS User Guide

1. INTRODUCTION

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 14971:2019 and 21 CFR 820, making it applicable for both the EU and the US markets.

Benefits

  1. Kick-starts your FDA and MDR 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 finalising your own QMS documentation.

A short video clip of SoftComply eQMS:

Medical Device Quality Management System in Confluence
Medical Device Quality Management System in Confluence

2. QUICK USER GUIDE

2.1. For Confluence Server and Data Center

  1. Install the SoftComply eQMS add-on from Atlassian Marketplace to your Confluence Server/DC instance. You need Confluence administration permissions to do that.

    Note that the evaluation version of the SoftComply eQMS for Confluence Cloud only displays screenshots of the partial content of the add-on and creating the eQMS space in the trial version is disabled. After installing the full version of the SoftComply eQMS for Confluence Cloud, creating the space works exactly the same as in the Server version of the add-on.
  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:
    1. Fill in Space Name, Space Key and the name of the Space editors;
    2. Define Header and Footer content of all pages in the eQMS.

2.2. For Confluence Cloud

The following spaces are installed in your instance:
1. eQMS Draft
This is the space where the QMS content is initially installed. Once approved, draft documents are published in the eQMS space (published space)
2. eQMS
This space contains the published versions of the QMS documents. All users should have access to this space.
3. Example QMS
This space contains a filled-in copy of most of the templates in the QMS. It is a valuable reference on how to complete the content.
4. Product Specifications DRAFT
This space is intended to be used with the draft version of product specifications, including labels and IFU. Once approved, draft documents are published in the Product Specifications space.
5. Product Specifications
This space contains the published versions of the Product Specifications
6. Quality Records
This space is an example of how to manage quality records. We do not suggest to put all your records in the same space. Create copies of this space to store different records as per your preferences.
7. Standards
This space is an example of how to manage external standards. All users should have access to this space.
8. CAPA, Change Requests, Complaints, NCs, Training
This spaces manage CAPA, Change Requests, Complaints, NCs and Training records. It includes a specific workflow, reporting and macros.
9. eQMS Supporting Pages Space
This spaces contains header, footer and Terms and Definition pages. These pages are used in almost every QMS document.

3. SET UP YOUR QMS

  1. Customize permissions
    1. Modify the space permissions according to the company requirements, if necessary;
    2. NOTE: a minimum number of users need to have edit permissions in the published spaces, otherwise the workflows will not publish pages correctly.
  2. Customize Header and Footer in the eQMS Supporting Pages Space
  3. The setup is complete!

You have now created your company’s QMS space that contains the Quality Manual, the Quality Policy, 25 SOPs and 74 Templates. The Home Page of your QMS space provides you with a checklist for implementing the QMS throughout your company.

The starting page provides you with a detailed look into each of the tasks in the checklist on your QMS Home Page that are required for setting up your QMS.

4. CUSTOMISE YOUR QMS

General

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 and in information-boxes that requires your attention and completion.

You should fill in this information based on the guidance described inside each box.

  1. The Quality Manual needs a certain amount of customization as it should reflect the business model, structure and products of your company;
  2. The Quality Policy needs to be defined by your company
  3. Some SOPs require you to enter the name or roles of people responsible for certain processes.

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 “Document Header” page in the “eQMS Supporting Pages Space” 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.

This macro displays the logo or picture from a source page.

Adding your company name

Before setting up you Company’s QMS, 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.

Just open and Edit the “Document Footer” page in the “eQMS Supporting Pages Space” and replace the default logo with the one of your choice.

Review the SOPs and Templates to ensure that the name appears correctly throughout

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. 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 info@softcomply.com or BOOK A DEMO with our Regulatory Team.

5. ROLL 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.

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.

Deploying Templates

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

1.2. Others

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.

Copying Templates

Each QMS template can be used for a specific scope or project by using the standard Confluence “Copy” function in the Page Actions.

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.

6. GUIDE TO CUSTOMISATION

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.

NOTE! Should you need additional support to finalise your QMS, please contact us. We are happy to support you – simply book a DEMO CALL with our Regulatory Team.

7. BOOK A DEMO

We are happy to support you – please send us an email at info@softcomply.com or simply BOOK A CALL with our Regulatory Team.