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What's New in March 2021

We released a new version of the SoftComply Risk Manager Cloud this week and in this Newsletter we will tell you about the new features and improvements we have made.

You can also read about:
* The regulatory compliance journey of one of our Austrian clients, Biome Diagnostics;
* Check out the podcast episode on benefits of automating compliance on Atlassian stack;
* Register to our upcoming webinars on Medical Device Regulations & Quality Management System implementation in Confluence (April 1st) and Risk Management in Jira (April 8 and 15).

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Do It Yourself Risk Table Template

We have recently added a Do It Yourself table template in the Risk Project Creation wizard. This template enables you to build the risk table from scratch completely by yourself. It only provides two columns to start with – Risk ID (Jira issue ID) and Risk Summary (Jira issue summary). Thereafter, you can add the fields you wish to see in your risk management table. Read more about the new template here.

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Freezing Risk Table Panes

Do you remember how you could freeze the table panes (column and row headers) in Excel when you had large tables so that you would know which risk each row corresponded to?

In the risk table of the SoftComply Risk Manager, you can also freeze the column headers that would allow you to have a quick overview of the data as you scroll down your table.

We have now added also a feature where you can see which risk you are working with when you move to the right of the table, i.e. away from the beginning of the risk row. When you are moving away from the beginning of a risk row, you will now be able to see the risk ID (Jira issue ID) and the risk summary fields when hovering over a risk row. This ensures that you are editing the risk you intended to edit. Read more about the new feature here.

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Due Date with Version/Release Number

Users can add various types of new columns to the Risk Management Table of the SoftComply Risk Manager. One such column type is Jira fixVersion field that allows you to link your risks to a specific software or project release. Jira fixVersions field is used to track time-based milestones in a project and organize releases.

To provide you with a better visual display of the versions and when they are due, we have added additional information to be displayed with the fixVersion field. You will now have the possibility to see the release number together with the release date in the risk table view. Read more about this new addition here.

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Risk Matrix Dashboard Gadget

Dashboard gadgets provide a great way to quickly build and display risk reports. One such SoftComply Risk Manager gadget displays Risk Matrices and thereby visualises how risks have been mitigated to acceptable levels.

Once you have created such a report, you can quickly move from the dashboard back to your risk table to see which of the risks are in a specific risk class. Simply click on any of the risk count numbers in the dashboard gadget and you will be taken to a filtered risk table showing only the risks of that specific risk class. Read more about the SoftComply Risk Manager dashboard gadget here.

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Biome Diagnostics GmbH is an Austrian medtech start-up utilizing the genetic information of the microbiome and AI to develop medical diagnostic software for doctors. Biome Dx products utilize technologies such as next-generation sequencing, pipeline architectures and microservices. With their lifestyle product myBioma every European has the possibility to learn more about their gut microbiome and improve lifestyle and diet. Furthermore, the product enables to optimize their technical development flow. Since 2020, Biome Dx is the very first company in the microbiome field in the world that is certified according to ISO 13485 and ISO 9001.

Biome Dx has written a fantastic tutorial to all agile medical device startups out there on how to prep and rock the ISO 13485 audits. A summary of their own compliance journey is provided here.

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Join our webinars and training courses to learn more about:

* Medical Device Regulations & implementing a compliant Quality Management System (next webinar on April 1st),

* Medical Device Risk Management in Jira (next webinar on April 8th)

* Establishing Risk Traceability in Jira and Confluence (next webinar on April 15th).

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PODCAST EPISODE ON AUTOMATING COMPLIANCE ON ATLASSIAN

SoftComply was invited to talk about regulatory compliance software tools in Quality Injection podcast.

To listen to the episode please continue here.

To check out additional episodes of the podcast on a range of topics relevant to medical device manufacturers, please see the channel here.

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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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