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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 April Newsletter brings you the latest updates about risk management on Jira, our FDA 21 CFR 11 compliant Quality Management Solution on Confluence, Amendment to the MDR postponing it for 1 year and more.

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In the previous blog post we compared the features of the top 4 Risk Management apps on Jira Server.

In this blog post, we compare the features of the most popular Risk Management apps on Jira Cloud.

There are only two popular Risk Management apps on Jira Cloud. One of them is for product and project risk management (SoftComply Risk Manager) and the other for organisational risk management (Risk Register) purposes.

The SoftComply Risk Manager offers three risk management templates – Hazard Analysis, FMEA and a Simple Project Risk Management template, and is fully customisable to any risk management project.

The organisational risk management app (Risk Register) has been developed for managing organisational risks and is based on ISO 31000 risk management process.

To compare the features of the two Risk Management apps, the table illustrates the apps’ main use cases, their ease of use and customisability, risk visualisation, risk mitigation, risk traceability, and risk reporting functionalities.

...to continue reading...

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HOW TO GET MORE OUT OF THE SOFTCOMPLY RISK MANAGER

Welcome to SoftComply's Knowledge Base!

Here you can learn everything about the features of our Risk Management apps as well as about useful tricks and tips to get the most out of our apps!

As companies have different risk management practices they may need various automation features that are not yet built into the SoftComply Risk Manager. Nevertheless, a lot can already be achieved when using the SoftComply Risk Manager together with Jira's scripting apps. The following set of articles addresses various activities that can be automated with the scripting apps.

Learn more about how you could use scripting apps together with the SoftComply Risk Manager.

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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, CAPA, Training and Change Management 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 Atlassian & Compliance

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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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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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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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