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What's New in May 2021

Great news for all SoftComply Risk Manager app users - you can now create a new risk project from an existing risk project. This new feature will copy the configuration of the risk matrices and the risk table from your existing risk project to a new one thereby fast-tracking the setup of your new risk project.
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CLONE YOUR RISK PROJECT CONFIGURATION

If you have already created risk projects with the SoftComply Risk Manager or the Risk Manager Plus, you can now create a new risk project from an existing one!
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SoftComply Risk Manager on Jira Cloud

Should you want to create a new Risk Project with the same or similar risk matrix and risk table configuration as one of your existing risk projects, you can also clone that existing configuration.

You can do that by going to the Apps drop-down menu and selecting the Risk Manager, then clicking "Create a new Risk Project from Existing Risk Project" button in the Cloud version.

Creating a new risk project from an existing one will copy the risk matrices and the risk table configurations together with the configuration schemes from the existing project.

Risk data itself will not be copied from the existing project.

Configuration of the risk matrices and the risk table can further be customized after the new risk project has been created.
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SoftComply Risk Manager and Risk Manager Plus on Jira Server/DC

Should you want to create a new Risk Project with the same or similar risk matrix and risk table configuration as one of your existing risk projects, you can also clone that existing configuration.

You can do that by selecting the “Clone Project Configuration” menu item from the Risk Manager drop-down menu in the Server version.

When you create a new risk project from an existing one you will be copying the risk matrix and risk table configurations into the new project together with the configuration schemes from the existing project.

The risk data itself will not be copied to the new project.

Configuration can be customized after the new risk project has been created. The schemes that are being copied are the following: Issue Type Scheme, Permission Scheme, Priorities Scheme, Issue Type Screen Scheme. If you are using single or multi-select fields in the risk table with project specific options, please review the configuration of custom field options.

In case you would like to learn more about this feature or have any questions about it, please don't hesitate to contact us.
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Risk Management Guide for a Digital Health or a Medical Device Company on Jira Cloud

Compliant Risk Management is a mandatory regulatory requirement for companies in medical device and other safety-critical domains. It is a specific aspect of safety-critical system development that requires linking risks to system/software design and testing to ensure the system is safe to use.

Various standalone solutions exist today for safety-critical system developers that help automate regulatory compliance but almost all of them cover the entire software development lifecycle.

The most common checklist for medical device companies looking for a risk management solution are the following:

1. Affordable – No scary numbers;
2. Pay-as-you-go license fee – better than one-offs; no need for capital requests, lump sums that require lengthy approval processes;
3. Integrates with the software tools used in the company, i.e. does not require additional effort to learn the tool – more training? No thanks;
4. Embeds guidance into the tool – a great tool is useless if you don’t know how to use it;
5. Fully customizable i.e. allows usage across departments, teams and plants regardless of the risk management method used – makes everybody happy;
6. Automates traceability, the nightmare for QAs;
7. Requires no effort from IT being cloud-based yet reliable and secure – IT will love it.
1. Affordable – No scary numbers;
2. Pay-as-you-go license fee – better than one-offs; no need for capital requests, lump sums that require lengthy approval processes;
3. Integrates with the software tools used in the company, i.e. does not require additional effort to learn the tool – more training? No thanks;
4. Embeds guidance into the tool – a great tool is useless if you don’t know how to use it;
5. Fully customizable i.e. allows usage across departments, teams and plants regardless of the risk management method used – makes everybody happy;
6. Automates traceability, the nightmare for QAs;
7. Requires no effort from IT being cloud-based yet reliable and secure – IT will love it.

For the full guide, please keep reading from here.
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SOFTCOMPLY KNOWLEDGE-BASE

There are numerous articles in the SoftComply Knowledge-base including:

▪ How-To benefit from the SoftComply Risk Manager features and customization options,
▪ Frequently Asked Questions on why the Risk Manager works the way it does and how you can change various settings,
▪ Additional Tips & Tricks for adding automation on top of the SoftComply Risk Manager features.
▪ How-To benefit from the SoftComply Risk Manager features and customization options,
▪ Frequently Asked Questions on why the Risk Manager works the way it does and how you can change various settings,
▪ Additional Tips & Tricks for adding automation on top of the SoftComply Risk Manager features.
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JOIN OUR WEBINARS & TRAINING COURSES
SoftComply at Digital Tech Summit 2019 - small

Join our webinars and training courses to learn more about:

▪ Regulations & compliant Quality Management System - Register here,
▪ Risk Management in Jira - Register here,
▪ Establishing Risk Traceability in Jira and Confluence - Register here.
▪ Regulations & compliant Quality Management System - Register here,
▪ Risk Management in Jira - Register here,
▪ Establishing Risk Traceability in Jira and Confluence - Register here.
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VIDEO CLIPS ON BUILDING COMPLIANCE ON JIRA & CONFLUENCE

In case you cannot join the webinars, feel free to check out the webinar recordings in our YouTube channel about:

▪ Medical Device Regulations & the FDA compliant QMS Solution in Confluence,
▪ Risk Management in Jira with the SoftComply Risk Manager app, and
▪ Establishing Risk Traceability in Jira and Confluence.
▪ Medical Device Regulations & the FDA compliant QMS Solution in Confluence,
▪ Risk Management in Jira with the SoftComply Risk Manager app, and
▪ Establishing Risk Traceability in Jira and Confluence.
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Recent posts on SoftComply Risk Manager & eQMS

On Safety-Critical Risk Management on Jira:
* What is a Risk Management File?
* How to Build a Risk Analysis in Jira?
* How to create an Organisational Risk Register with SoftComply Risk Manager?
* Comparison of Risk Management Apps on Jira Cloud
* Comparison of Risk Management Apps on Jira Server
* Hazard Analysis & FME(C)A on Jira
* What is FMEA?

On Quality Management on Confluence:
* Customer Stories on Successful Compliance Audits using the SoftComply eQMS Solution on Atlassian Confluence
* How to turn Confluence into a Compliant Document Management System for Medical Devices
* How to Add Page Numbers to PDF Export of Confluence Pages
* Comparison of SoftComply eQMS & the MediCompli Solution
* Don't be a "Victim" of your Quality System!
* How to set Page Level Restrictions in Confluence

On Regulatory Compliance on Atlassian Stack:
* 3 Must-Have Considerations when Setting up Atlassian in your Organisation
* Top 3 Features of an Electronic Document Management System for Medical Device Companies
* Cybersecurity in Medical Devices
* The Six Must-Have Atlassian Apps for Medical Device Companies
* Medical Device Compliance and Atlassian Cloud
* 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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