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We hope you and your loved ones are safe during these challenging times!

Our May Newsletter brings you the latest updates on how to build an organisational risk register in Jira, how to implement an FDA 21 CFR 11 compliant Quality Management system in Confluence and more. We'd also like to request your help in prioritising the next features for SoftComply Risk Manager we plan to develop.

In light of the global Covid-19 crisis & the importance of medical innovations in today's world, we have considerably lowered the prices of the SoftComply Risk Manager on Jira Cloud!!!


REQUEST FOR HELP! - to prioritise new features of the SoftComply Risk Manager

There are several new features we plan to develop over the next 12 months but we would like to ask your help to prioritise them.

Please prioritise the new features in the anonymous Google Form. You can also list any additional features you would like to see in the Risk Manager.


What is a Quality Management System?

You probably know that Medical Device companies are required to have a Quality System in place, in order to be able to market their products in most countries in the world.

This Quality System, or Quality Management System – QMS, is a collation of Procedures, documents, templates and records that describe and dictate how certain activities must be carried out for medical device products. This QMS must conform to certain requirements, most commonly ISO 13485 (EU, Canada, Australia) and 21 CFR 820 (USA).

The SoftComply eQMS is exactly this. A system of electronic documents (thus the “e” of eQMS), conforming to ISO 13485, IEC 62304, ISO 14971 and 21 CFR 820, and growing.

You will find a Quality Manual, that explains how the QMS is organized and the different aspects of the regulations covered, a Quality Policy, a brief statement that aligns with your organization’s purpose and strategic direction, provides a framework for quality objectives, and includes a commitment to meet applicable requirements, and a set of Procedures (20 SOPs) and 55 Technical Document Templates.

All documents are prefilled and embed guidance for you to finalize. It is a self-sufficient system, where the Procedures explain the processes and the Templates are used to gather and document the required information.

Any QMS then needs a “home”, i.e. an official repository or place, physical or electronic, where the documents reside. It is possible to have a paper-based QMS, where the documents are printed and managed in their paper form, but this defies the purpose of having an electronic system.

The SoftComply eQMS lives within Confluence, where Confluence is more than a mere editor like Word, but it actually “manages” the documentation for aspects such as versioning, links, references, grouping in Spaces, and so on. Confluence is now a “Document Management System” and the eQMS is only a portion of what a company may store in Confluence. In addition, signing electronic documents is a natural expectation in a Document Management System; Confluence does not have any built-in signature capability, but there are Apps, such as Comalatech’s products, that fill this gap.

Document Management Systems (DMS) with e-signatures, must abide to certain requirements, in the Medical Device market, such as preservation of the documents, their availability, access control, and more. These requirements are relatively loose in Europe, but FDA 21 CFR 11 in the USA list a number of detailed clauses that make it not that trivial to comply with. While having your eQMS on Confluence Cloud with a basic electronic signature app may be sufficient for the EU, the US market requires a more complex ecosystem.

The MediCompli solution is what you need for the US market. It expands and configures the Confluence Document Management System to be fully FDA 21 CFR 11 compliant. MediCompli comes with a pre-installed SoftComply eQMS for completeness, but the two objects are independent. The MediCompli extends the SoftComply eQMS with FDA compliant Document Approval, CAPA, Training and Change Request workflows and compliant access management.

The eQMS is the actual content and can be used on any Confluence instance, cloud, server or datacenter, while the MediCompli Solution is a Compliant Document Management System that will contain more than just the eQMS.

To learn more about the SoftComply eQMS and/or the MediCompli solution, please drop us an email to arrange a demo call. After the demo call, you will also be able to try out the solution in a trial environment.


The aim of this post is to guide you through the development of an organisation-wide Risk Register with SoftComply Risk Manager. This Risk Register supports risk management across your organisation providing your team members with a list of risks that apply to a specific product or project.

To achieve that, we will first create a solution where we have one “Risk Register” project that contains all the risks of your organisation. The purpose of the Risk Register project is to manage the mappings between all the risks in the organisation i.e. the risk register and the project specific risks of certain products/projects. Next, we’ll add the logic that clones the risks of the risk register into the specific risk projects while keeping the data up to date based on the previously created mapping. Now, every time that you add a risk to the risk register and apply it to a specific product, the risks in the specific risk projects are updated automatically at the same time!

... for full instructions on how to build the risk register, please continue reading...


Benefits of the SoftComply Risk Manager PLUS for Jira Server:

▪ Supports Hazard Analysis and FMEA
▪ Supports FMEA with Detectability
▪ Displays risks in Matrices & RPN
▪ Supports FDA approval and CE-marking process
▪ Targeted towards safety critical domain users
Supports Hazard Analysis and FMEA
Supports FMEA with Detectability
Displays risks in Matrices & RPN
Supports FDA approval and CE-marking process
Targeted towards safety critical domain users

For full list of features of SoftComply Risk Manager PLUS, please check out the User Guide. Try it out for free for a month and/or contact us to get a demo & discussion about the features.


Benefits of the SoftComply eQMS:

▪ Full Quality Management System for medical device co-s
▪ On ISO13485, IEC62304, ISO14971, FDA 21CFR 820
▪ Fully customizable with embedded guidance
▪ Reduces the cost of compliance
▪ Most competitive price
Full Quality Management System for medical device co-s
On ISO13485, IEC62304, ISO14971, FDA 21CFR 820
Fully customizable with embedded guidance
Reduces the cost of compliance
Most competitive price

SoftComply eQMS on Confluence Cloud:

The new MDR states that Quality System documents need to be searchable. You can now implement a compliant Quality System documentation on your Confluence Cloud! Access the free trial version directly from the Atlassian Marketplace and/or contact us to get a demo & discussion about the content of the product.


Benefits of the SoftComply Risk Manager:

▪ Supports any software system/product risk management
▪ For both Jira Server & Cloud users
▪ Fully customizable for any type of risk project
▪ Automated traceability
▪ Support software system/product risk management
▪ Most competitive price
Supports any software system/product risk management
For both Jira Server & Cloud users
Fully customizable for any type of risk project
Automated traceability
Support software system/product risk management
Most competitive price

For full list of features of SoftComply Risk Manager, please check out the User Guide. Try it out for free for a month and/or contact us to get a demo & discussion about the features.

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