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What's New in December 2020

Earlier this week we released a new version of the SoftComply Risk Manager Cloud and in this Newsletter we will tell you what is the brand new feature that many of you have patiently been waiting for.

You can also read about how to add page numbers to PDF exports of Confluence pages, something auditors are often looking for in quality records.

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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Applying Risk Manager features to all Jira projects

Many of you have asked us to enable SoftComply Risk Manager features to all of your existing Jira projects.

This can now be done!

How to enable Risk Manager to all projects?

You can now add SoftComply Risk Manager views to any of your existing Jira projects. It does not matter whether it’s a Scrum, ServiceDesk or a simple business project. To enable the Risk Management just open Project Settings (in order to do that you need Jira project admin permissions at a minimum) and select “Enable Risk Management”.

After clicking “Enable Risk Management” you will need to choose the risk matrix template, risk management table template and the type of Jira issues that represent risks in this project. All your chosen templates can be customised later as both the matrices and the table layouts are fully customisable. You can also change the risk issue type(s) later if needed.

NB! Only the issues with the selected Jira issue types are considered to be risks and are thereby visible in the Risk Table view as well as in the Risk Reports. If you want to manage additional issues in the risk table view as well, all you need to do it to add their Jira issue types in the Project Settings.

For more instructions on how to set up and update your settings for enabling Risk Manager in your Jira projects, please read on here.

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Paper-based Quality Management Systems are now (almost) a thing of the past (it’s sooo 20th century…).

But in some cases, printing records and documents from the eDMS is necessary, or at least exporting them to PDF. The requirements for paper documents are the same as digital documents. But, unlike electronic formats, physical misplacement or loss of pages is a real risk. The solution is quite simple: page numbers. This will allow the user to easily sort the pages and determine what the last one is.

Each page should have its number in the following format – “Page X of Y”.

It seems obvious, but check how many times you have received documents from a bank or a lawyer without page numbers.

In Atlassian Confluence, pages are a continuous stream of content and there is no paging as such. The built-in PDF export does not add page numbers by default. Some apps are available to heavily customize PDF layouts, but for a simple page numbering we can provide you with a quick and easy solution using CSS for PDF Stylesheets.

For a simple 3-step guide to adding page numbers to your Confluence page PDF exports, please read on here.

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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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