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

In case you have read your share about the Coronavirus and are looking for some lighter reading, we are most happy to provide it to you.

Our March Newsletter brings you the latest updates about risk management on Jira, our FDA 21 CFR 11 compliant Quality Management Solution on Confluence, European Commission proposal to postpone MDR for 1 year and more.
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COMPARISON OF THE TOP 4 RISK MANAGEMENT APPS ON JIRA SERVER
Aug2019

In the following post we compare the features of 4 top risk management apps on Jira Server.

There are four popular apps on Jira Server for risk management purposes. Two of them are for product risk management and the other two for project risk management purposes.

The product risk management apps (SoftComply Risk Manager and SoftComply Risk Manager Plus) have been developed with safety critical product risk requirements in mind as they follow the requirements specified in ISO 14971 yet customizable to any software product risk management project. You can read more about the safety critical product risk management requirements here.

The project risk management apps (Risk Register and Risk Management for Jira) have been developed for managing project and organizational risks in mind, where the former is based on ISO 31000 risk management process and the latter is a more generic risk management app.

Following is a closer look at each of the four apps to provide you an overview of the main use cases of each of them, their risk management methods, risk visualization options, and their risk measurement, risk mitigation, risk traceability and risk reporting functionalities as well as an overview of their ease of use.

To compare the features of each of the four risk management apps, we first provide an overview of them in the table below. To learn more about each of the apps and their features, please continue reading after the table.

...to continue reading...
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Risk Manager logo no company name

NEW FEATURES OF RISK MANAGER CLOUD

SoftComply Risk Manager on Jira Cloud now has the following new features:

▪ Initial and Residual Risk Class and Risk parameters, i.e. Probability and Severity are now visible and editable in Jira issue view;
▪ Dashboard gadget for Risk Matrices;
▪ FMEA template as a new risk project type;
▪ Generic project risk management template as a new project type;
▪ All templates have multi-line text fields (TextArea) by default (for more than 255 chars);
▪ New columns of Single Select type can now be added to the risk table;
▪ Audit trail improvement of new links added to risks (user who added links is specified in Jira issue view).
▪ Initial and Residual Risk Class and Risk parameters, i.e. Probability and Severity are now visible and editable in Jira issue view;
▪ Dashboard gadget for Risk Matrices;
▪ FMEA template as a new risk project type;
▪ Generic project risk management template as a new project type;
▪ All templates have multi-line text fields (TextArea) by default (for more than 255 chars);
▪ New columns of Single Select type can now be added to the risk table;
▪ Audit trail improvement of new links added to risks (user who added links is specified in Jira issue view).

How can I benefit from it?
Now risk managers can easily view and edit risk parameters not only in the risk table but also in the Jira issue view. The new template for generic risk management supports project risk management in addition to your product risk management templates of FMEA and Hazard Analysis. Risk Managers can now also create new Single Select type columns to the risk table. This type of column could be used to, for example, specify the subsystem where each risk is coming from. Finally, users can now see who created or edited links between risks in the Jira issue view. This feature supports better audit trail functionality.
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FDA 21 CFR 11 COMPLIANT QMS SOLUTION ON CONFLUENCE
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SoftComply together with Comalatech and Clearvision are happy to present the very first FDA 21 CFR 11 compliant electronic Quality Management System on Confluence!

This Confluence based solution includes a full QMS documentation, digital document control with document approval workflows and e-signatures as well as compliant access management. The solution is pre-configured, maintained and hosted on AWS according to your company needs.

To learn more about this solution, please visit MediCompli product page, read a short blog post about the solution or take a look at the MediCompli video where we introduce the features of the solution.

In case of interest or to arrange a call to learn more about it, please contact us.
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Useful Reading on MedTech, Compliance & Atlassian
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1. Video clip about EC proposal to postpone MDR for 1 year due to COVID-19
2. List of the 12 MDR Designated Notified Bodies in Europe
3. Atlassian expands its free software offer
4. How changes in Jira 8.8 Server and Data Center improve your Audit logs
5. Latest news from Atlassian Ecosystem
6. SoftComply, Assemblient and Fledge Innovation Lab fighting against the spread of COVID-19
1. Video clip about EC proposal to postpone MDR for 1 year due to COVID-19
2. List of the 12 MDR Designated Notified Bodies in Europe
3. Atlassian expands its free software offer
4. How changes in Jira 8.8 Server and Data Center improve your Audit logs
5. Latest news from Atlassian Ecosystem
6. SoftComply, Assemblient and Fledge Innovation Lab fighting against the spread of COVID-19
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Recent posts on SoftComply Risk Manager & SoftComply eQMS

On Safety-Critical Risk Management on Jira:
* How to set notifications for your risks in Jira
* New Features of SoftComply Risk Manager and Risk Manager Plus
* What is tool validation?
* Managing Safety-Critical Product Risks in Jira
* How to mitigate Medical Device Risks in Jira
* Hazard Analysis & FME(C)A on Jira
* What is FMEA?

On Quality Management on Confluence:
* How SoftComply eQMS helped speed up the CE-marking - Case Study
* Don't be a "victim" of your Quality System!
* SoftComply eQMS for Medical Device companies on Confluence
* How to set page level restrictions in Confluence

On Regulatory Compliance of Medical Devices:
* On FDA, Compliance and Cloud tools
* Overview of Medical Device Software Regulations and Standards
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RiskManagerPLUS Logo

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.
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eQMS logo no company name

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.
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Risk Manager logo no company name

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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