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What's New in February 2021

We released a new version of the SoftComply Risk Manager Cloud a week ago and in this Newsletter we will explain what is new there.

You can also read about the three most important aspects that you should keep in mind and manage when setting up your organization on Jira and Confluence, especially in case your organization is in the regulated domain.
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NEW IN SOFTCOMPLY RISK MANAGER CLOUD
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Link you risks with fixVersion Jira field

When you are using the SoftComply Risk Manager on Jira Cloud, you can create several new Jira fields in the risk table. One of those fields is now the fixVersion Jira field that supports linking your risks to a specific version of software.

fixVersion is the version field where you plan on releasing a feature or bugfix to customers. This field is used for release planning, monitoring progress and velocity, and is used widely in reporting. In other words, if you use Jira to plan and monitor your progress, you'd surely also use the fixVersion.

Connecting risks with fixVersion allows you to also manage risks in the context of your software releases. It helps planning your risk management activities and provides easy reporting when filtering the risk table by the fixVersion.
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3 THINGS YOU MUST CONSIDER WHEN SETTING YOUR ORGANIZATION UP ON ATLASSIAN JIRA & CONFLUENCE
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Atlassian tools like Jira and Confluence are well known for their flexibility and customization. When most software developers prefer this flexibility over closed systems, the regulated industries may often fear that this flexibility could affect their compliance. There are aspects that you will have to consider when setting your organization up on Atlassian stack when you are in a regulated domain.

We have broken it down to 3 areas that you must consider when setting your organization up on Atlassian stack when you are working in a regulated domain.

I ARE WE DOING THNIGS IN THE RIGHT WAY?

The first thing to consider is how to set up your organization’s processes in Jira and Confluence. Every organization works differently but regulations require each company to have well defined processes in the form of SOPs (Standard Operating Procedures). It’s crucial that you get most out of your tools by configuring them in a way that supports your existing processes. Read more here.

II WHO CAN SEE WHAT?

The second aspect of configuration consideration in the regulated domains is securing your data so only the authorized users can see them. It is expected that you have procedures that define, at a high level, the different access levels to each tool. Read more here.

III WHERE IS MY DATA?

Last but not least, you should consider data residency. Data residency is about the location in which your data is being stored. It is an important aspect when choosing a cloud operator for the regulated domains. GDPR (EU) requires processing and storing of personal data to be within the EU. Read more about Atlassian data storage here.

For full article, please continue reading here.
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NOTIFICATION TO MEDICOMPLI CLOUD USERS
MediCompli console

This is an improvement notice for everyone who is using MediCompli solution on Confluence Cloud.

A recent update to Comala Document Management Cloud (18 Feb 2021), now allows the user to have steps with transitions to other states. This is particularly useful if you want to move a page to a different state without any approval and with a single button to click.

A viable application to the MediCompli Cloud workflow is to replace the Approval in the initial state of a page with a Transition.

In case you would like to do that, please follow these steps:

▪ Create a backup of the workflow;
▪ Edit the workflow with the workflow editor;
▪ Click on the initial state of the workflow;
▪ Click on Approvals;
▪ Select the current approval;
▪ Click on "Delete" at the bottom of the tab;
▪ Click on Transitions;
▪ Remove all transitions related to Approval or Rejection of the page;
▪ Select the "Select" transition type from the dropdown list;
▪ Select the required state(s);
▪ Click on "Apply" at the bottom of the tab;
▪ Save the workflow.
▪ Create a backup of the workflow;
▪ Edit the workflow with the workflow editor;
▪ Click on the initial state of the workflow;
▪ Click on Approvals;
▪ Select the current approval;
▪ Click on "Delete" at the bottom of the tab;
▪ Click on Transitions;
▪ Remove all transitions related to Approval or Rejection of the page;
▪ Select the "Select" transition type from the dropdown list;
▪ Select the required state(s);
▪ Click on "Apply" at the bottom of the tab;
▪ Save the workflow.

In case you run into any problems or would like to discuss with us before changing your workflows, please don't hesitate to contact us.
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JOIN OUR WEBINARS & TRAINING COURSES
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Join our webinars and training courses to learn more about Medical Device Regulations, Medical Device Risk Management & implementing an FDA Compliant Quality Management System on Atlassian Stack.
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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.
SoftComply YouTube Channel
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JIRA TRAINING COURSES ON OFFER

Check out & join our brand new Atlassian Jira online training courses!
Jira Courses
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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 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:
* How to turn Confluence into a Compliant Document Management System for Medical Devices
* Comparison of SoftComply eQMS & the MediCompli Solution
* How SoftComply eQMS helped speed up the CE-marking - Case Study
* Don't be a "Victim" of your Quality System!
* How to set Page Level Restrictions in Confluence

On Regulatory Compliance of Medical Devices:
* What is MDR Up-Classification and its Extension
* MDR: Equivalence in Clinical Evaluations
* Cybersecurity in Medical Devices
* The Six Must-Have Atlassian Apps for Medical Device Companies
* 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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