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What's New in October 2020

Last week Atlassian announced the end of Server license sales and support and in this October newsletter we discuss how the Regulated Industries can continue working on Atlassian.

You can also read more about our Support for Migration from Server.

We also introduce the latest product improvements made to the SoftComply Risk Manager and Risk Manager Plus.

Finally, we wanted to inform you that in light of the global Covid-19 crisis we have once again lowered the prices of the SoftComply Risk Manager on Jira Cloud!!!

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On the 16th of October 2020, Atlassian announced radical changes to their offering.

From February 2nd 2021, Atlassian will stop selling new Server licenses for any of their products.

A year later, in February 2022, it will not be possible to upgrade or downgrade your Atlassian Server product tier.

From February 2023, it will not be possible to buy new Atlassian Server apps.

The last deadline, February 2024, will see no license renewal available for Server products, and that will be the end of Atlassian Server support.

Of course, as Server licenses are perpetual, Server users may continue their operation on the existing version and configuration of their existing system.

A Light at the End of the Tunnel

It’s not all doom and gloom in Atlassian Cloud.

Atlassian recognises the importance and the complexity of the regulations we have to comply to in the Medical Device industry. They are moving towards providing a number of additional features to help bridge the existing gaps to compliance. Some examples for Confluence will include:

▪ Password policy is available for all tiers;
▪ Audit logs are available for all subscription tiers;
▪ Encryption in transit and at rest is available for all tiers;
▪ Sandbox mode and Release Tracks will be available for Cloud Premium and Cloud Enterprise versions;
▪ Data residency is currently available only for Cloud Enterprise plans;
▪ Apps will be allowed to manage their own data residency for GDPR purposes;
▪ Atlassian will be HIPAA compliant.
Password policy is available for all tiers;
Audit logs are available for all subscription tiers;
Encryption in transit and at rest is available for all tiers;
Sandbox mode and Release Tracks will be available for Cloud Premium and Cloud Enterprise versions;
Data residency is currently available only for Cloud Enterprise plans;
Apps will be allowed to manage their own data residency for GDPR purposes;
Atlassian will be HIPAA compliant.

The most important of all is the Sandbox and Release Tracks. With these tools a company will be able to “delay” updates for a couple of weeks while performing validation tests to ensure the integrity of the update. This will require a certain amount of automation, as it is not reasonable to re-validate your instance every 2 weeks.

In light of all of this, we at SoftComply have decided to focus our development efforts on automating the integrity check of Confluence before an update is released. Stay tuned!

For the full article that includes the impact of Atlassian decision on the Regulated Industries as well as your migration options regarding the Atlassian platforms, please read on here.

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Required Permissions

Each user must be given correct permissions in order to run Jira and the SoftComply Risk Manager app in a secure manner. Each action in Jira is secured by permissions and permissions can be granted to:

▪ Individual user
▪ Group
▪ Project role
▪ Special role (assignee, reporter, project lead)
▪ User or Group picker custom fields
▪ Anyone
Individual user
Group
Project role
Special role (assignee, reporter, project lead)
User or Group picker custom fields
Anyone

Correct and reviewed permissions also guarantee safe and secure risk management process. The SoftComply Risk Manager or the SoftComply Risk Manager Plus app permissions are explained in greater detail below and can slightly vary between platforms (Server/Data Center/Cloud).

User Roles in the SoftComply Risk Manager

In risk management we can outline two major roles that are also reflected the app permissions setup:

Risk Manager Administrators
Define and set up the risk management process i.e. define the configuration of the risk model and the spreadsheet (risk table) to manage risks in the organisation. The changes to the process are not frequent but they affect risk management in the entire company/product/project. In the context of Jira we can compare it to a project setup and/or project administration tasks.

Risk Manager Team members
Daily work with risks i.e. adding new risks, editing existing risks, creating/modifying mitigation and verification actions, etc. In the context of Jira the team members work with Jira issues.

To learn more about Risk Manager and Risk Manager Plus permissions, please read on here.

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This post is about XRGO'S regulatory compliance journey describing them moving from contract manufacturing of electronics to the FDA regulated world of medical devices as they started manufacturing PPE in response to Covid-19.

XRGO talks about their experience in implementing a Confluence based Document Management System with the MediCompli Solution.

Please continue here to read about XRGO's journey.

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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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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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Check out & join our brand new Atlassian Jira online training courses!

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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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