Table of contents
  • 1. INTRODUCTION
  • 2. QUICK USER GUIDE
    • 2.1. For Confluence Server and Data Center
    • 2.2. For Confluence Cloud
  • 3. COMPLIANCE MATRIX ISO 13485
  • 4. SET UP YOUR QMS
  • 5. CUSTOMISE YOUR QMS
  • 6. ROLL OUT YOUR QMS
  • 7. GUIDE TO CUSTOMISATION
  • 8. 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. COMPLIANCE MATRIX ISO 13485

The SoftComply eQMS features full compliance matrices for ISO 13485:2016, IEC 62305:2015 and ISO 14971:2019 and 21 CFR 820. Below is the compliance matrix between the SoftComply eQMS and ISO 13485.

This matrix between the SoftComply eQMS and ISO 13485:2016 is valid as long as the QMS processes are not modified. The Company is responsible for the update of the matrix after any change, as appropriate.

ISO 13485 Clause 4 – Quality management system

ClauseTitle or SectionSoftComply eQMS reference
4.1
General requirements
Title only
4.1.1First Paragraph1. The QMS content itself
2. Management Review SOP
3. Company Quality Management SOP
4. Regulatory Process SOP
5. Standards and Regulations Monitoring
Second Paragraph

1. The QMS content itself
2. Management Review SOP
3. Quality Manual par 2 (Scope) for applicable standards and regulatory requirements
4. Company Quality Management SOP
Third Paragraph & Note

1. The Quality Manual par 4.1.1 for the company role(s)

4.1.2a)1. The QMS content itself
2. Quality Manual par 4.1.2 for diagram of QMS processes
3. Quality Manual Appendix I for map of SOPs vs QMS processes
4. Company Quality Management SOP
b)1. Quality Manual par 4.1.2 for risk-based approach
2. Company Quality Management SOP
c) 1. Quality Manual par 4.1.2 Figure 1
2. Company Quality Management SOP
4.1.3a)1. Management Review SOP
2. Company Quality Management SOP
b)1. Management Review SOP
2. Resource Management SOP
3. Company Quality Management SOP
c)1. Management Review SOP
2. Company Quality Management SOP
d)1. Management Review SOP
2. Company Quality Management SOP
e)1. The QMS templates and any record created by the company
2. Company Quality Management SOP
3. Regulatory Process SOP
4.1.41. This compliance matrix and each SOP
2. Regulatory Process SOP
a), b), c)1. Change Management SOP “Impact Assessment“ section
2. Regulatory Process SOP
4.1.51. Quality Manual par 4.1.5
2. Purchasing and Supplier Management SOP
4.1.6First Paragraph1. Qualification and Validation SOP “Software tools and IT equipment“ section
Second Paragraph1. Qualification and Validation SOP “Software tools and IT equipment“ section
2. The guidance within each template
Third Paragraph1. Records of the validation of the application of computer software used in the quality management system and relative templates
4.2Documentation RequirementsTitle only
4.2.1General
a)
1. The Quality Policy
2. Quality Objectives (to be developed by the company management)
b)1. The Quality Manual
c)1. The QMS SOPs and records / templates
d)1. The QMS SOPs and records / templates
e)1. The QMS SOPs and records / templates
2. Regulatory Process SOP
4.2.2Quality Manual1. The Quality Manual
4.2.3Medical Device File1. Device Lifecycle SOP
2. Actual Medical Device File of a product
3. Regulatory Process SOP
4.2.4Control of Documents1. Document Control SOP
2. Regulatory Process SOP
4.2.5Control of Records1. Document Control SOP
2. Regulatory Process SOP

ISO 13485 Clause 5 – Management Responsibility

ClauseTitle or SectionSoftComply eQMS reference
5.1Management commitment
a)
1. Quality Manual section 5.1
2. Management Review SOP
3. Company Quality Management SOP
b)1. Quality Policy
2. Company Quality Management SOP
c)1. Quality Objectives (to be developed by the company management)
2. Company Quality Management SOP
d)1. Management Review SOP
2. Company Quality Management SOP
e)1. Resource Management SOP
2. Management Review SOP
3. Company Quality Management SOP
5.2Customer Focus1. Quality Manual section 5.2 and section 2
2. Management Review SOP
3. Company Quality Management SOP
5.3Quality Policy1. Quality Manual section 5.3
2. Quality Policy
3. Management Review SOP
4. Company Quality Management SOP
5.4PlanningTitle only
5.4.11. Quality Objectives (to be developed by the company management)
2. Company Quality Management SOP
5.4.2a)1. The QMS Itself
2. Quality Manual section 2
3. Company Quality Management SOP
b)1. Change Management SOP
2. Company Quality Management SOP
5.5Responsibility, authority and communication1. Company Quality Management SOP
2. Org chart in the Quality Manual
3. Resource Management SOP, including records of Job descriptions
5.5.1Responsibility and authority1. Company Quality Management SOP
5.5.2Management representative1. Company Quality Management SOP
5.5.3Internal communication1. Company Quality Management SOP
5.6Management ReviewTitle only
5.6.1General1. Management Review SOP
5.6.2Review Input1. Management Review SOP
5.6.3Review Output1. Management Review SOP

ISO 13485 Clause 6 – Resource Management

ClauseTitle or SectionSoftComply eQMS reference
6.1Provision of Resources1. Company Quality Management SOP
6.2Human Resources1. Resource Management SOP
6.3Infrastructure1. Resource Management SOP
2. IT Policy SOP
6.4Work environment and contamination controlTitle only
6.4.1Work Environment1. Resource Management SOP
6.4.2Contamination Control1. Resource Management SOP

ISO 13485 Clause 7 – Product Realization

ClauseTitle or SectionSoftComply eQMS reference
7.1Planning of product realization
First paragraph
1. Device Lifecycle SOP
2. Quotation and Service Providing SOP
Second paragraph1. Risk Management SOP
2. Device Cybersecurity SOP
a), b), c), d)1. Device Lifecycle SOP
7.2Customer-related processesTitle only
7.2.1Determination of requirements related to product1. Device Lifecycle SOP
2. Quotation and Service Providing SOP
3. Regulatory Process SOP
7.2.2Review of requirements related to product1. Device Lifecycle SOP
2. Quotation and Service Providing SOP
7.2.3Communication1. Quotation and Service Providing SOP
7.3Design and developmentTitle only
Note: detailed traceability for this clause can be found inside the Device Lifecycle SOP
7.3.1General1. Device Lifecycle SOP
7.3.2Design and development planning1. Device Lifecycle SOP
7.3.3Design and development inputs1. Device Lifecycle SOP
2. Regulatory Process SOP
3. Labelling and UDI SOP
4. Usability Engineering SOP
7.3.4Design and development outputs1. Device Lifecycle SOP
7.3.5Design and development review1. Device Lifecycle SOP
7.3.6Design and development verification1. Device Lifecycle SOP
7.3.7Design and development validation1. Device Lifecycle SOP
2. Clinical Evaluation SOP / Clinical Performance Studies SOP
3. Regulatory Process SOP
4. Usability Engineering SOP
7.3.8Design and development transfer1. Device Lifecycle SOP
7.3.9Control of design and development changes1. Device Lifecycle SOP
2. Change Management SOP
7.3.10Design and development files1. Device Lifecycle SOP
7.4PurchasingTitle only
7.4.1Purchasing process1. Purchasing and Supplier Management SOP
2. Regulatory Process SOP
7.4.2Purchasing Information1. Purchasing and Supplier Management SOP
7.4.3Verification of purchased product1. Purchasing and Supplier Management SOP
7.5Production and service provisionTitle only
Note: the Company may create more procedures specific for each product
7.5.1Control of production and service provision
First paragraph
1. Device Lifecycle SOP
2. Manufacturing SOP
a)1. Manufacturing SOP
b)1. Qualification and Validation SOP
c)1. Manufacturing SOP
2. Resource Management SOP
d)Resource Management SOP
e)1. Manufacturing SOP
2. Labelling and UDI SOP
f)1. Manufacturing SOP
2. Distribution, Installation and Servicing SOP
Last paragraph1. Manufacturing SOP
7.5.2Cleanliness of product1. Manufacturing SOP
7.5.3Installation activities1. Distribution, Installation and Servicing SOP
7.5.4Servicing activities1. Distribution, Installation and Servicing SOP
7.5.5Particular requirements for sterile medical devices1. Manufacturing SOP
7.5.6Validation of processes for production and service provision1. Qualification and Validation SOP
7.5.7Particular requirements for validation of processes for sterilization and sterile
barrier systems
1. Manufacturing SOP
2. Qualification and Validation SOP
7.5.8Identification1. Manufacturing SOP
2. Regulatory Process SOP
7.5.9TraceabilityTitle only
7.5.9.1General1. Manufacturing SOP
2. Regulatory Process SOP
7.5.9.2Particular requirements for implantable medical devices1. Manufacturing SOP
2. Purchasing and Supplier Management SOP
7.5.10Customer property1. Purchasing and Supplier Management SOP
7.5.11Preservation of product1. Manufacturing SOP
2. Device lifecycle SOP
3. Distribution, Installation and Servicing SOP
7.6Control of monitoring and measuring equipmentTitle only
first paragraph
1. Manufacturing SOP
2. Distribution, Installation and Servicing SOP
second paragraph1. Resource Management SOP
third paragraph, a), b), c), d), e)1. Resource Management SOP
fourth paragraph1. Resource Management SOP
fifth paragraph1. Resource Management SOP
sixth paragraph1. Resource Management SOP
seventh paragraph1. Qualification and Validation SOP
eight paragraph1. Qualification and Validation SOP

ISO 13485 Clause 8 – Measurement, analysis and improvement

ClauseTitle or SectionSoftComply eQMS reference
8.1General1. Manufacturing SOP
2. Company Quality Management SOP
3. Qualification and Validation SOP (statistical techniques)
8.2Monitoring and measurementTitle only
8.2.1Feedback
first paragraph
second paragraph
1. Feedback, Complaints and PMS SOP
third paragraph1. Feedback, Complaints and PMS SOP
2. Management Review SOP
3. Risk Management SOP
fourth paragraph1. Regulatory Process SOP
2. Clinical Evaluation SOP / Clinical Performance
3. Studies SOP
8.2.2Complaint Handling1. Feedback, Complaints and PMS SOP
2. Regulatory Process SOP
8.2.3Reporting to regulatory authorities1. Feedback, Complaints and PMS SOP
2. Regulatory Process SOP
8.2.4Internal audit1. Internal Audit SOP
8.2.5Monitoring and measurement of processes1. Management Review SOP
2. Company Quality Management SOP
8.2.6Monitoring and measurement of product1. Manufacturing SOP
8.3Control of nonconforming productTitle only
8.3.1General1. Manufacturing SOP
2. Non conformities SOP
8.3.2Actions in response to nonconforming product detected before delivery1. Manufacturing SOP
2. Non conformities SOP
8.3.3Actions in response to nonconforming product detected after delivery1. Non conformities SOP
2. Regulatory Process SOP
8.3.4Rework1. Non conformities SOP
8.4Analysis of data1. Management Review SOP
8.5ImprovementTitle only
8.5.1General1. Management Review SOP
2. Non conformities SOP
3. CAPA SOP
8.5.2Corrective action1. CAPA SOP
8.5.3Preventive action1. CAPA SOP

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.