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What's New in January 2022

In this January newsletter we will provide you with an overview of the apps and features we released in 2021 & the apps and features we are developing and will release in 2022.

We have also included a more detailed overview of our risk management apps on Atlassian Jira, their new reporting features and how these two apps compare to each other.
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HIGHLIGHTS OF 2021
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Thank you for joining our ever-growing community of safety-critical product developers on Atlassian stack!

Last year we released 2 new apps: the SoftComply Static Snapshots app & the SoftComply Risk Manager on Confluence Cloud.

The SoftComply Static Snapshots app is an integral part of the electronic Document Management System on Confluence to make sure that the content you are approving will not change after you have approved it.

The SoftComply Risk Manager extension on Confluence enhances your risk reporting as you can pull your risk data from your risk projects in Jira easily to your Confluence pages after which you can add text around the risks and get the risk report into approval.

You can try out both of these apps for 30 days for free but if you’d like to learn more about them before you start, feel free to book a demo call with us or join our free webinars.

In addition to the new app releases, we have made several improvements to our existing Risk Manager apps - creating a new risk project from an existing project (cloning the existing risk project configuration), support to all Jira field types in the risk table, new risk table template (Do It Yourself) to support the re-use of the existing Jira custom fields in a risk project.

WHAT'S IN STORE FOR 2022
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2022 will be a very exciting year as we plan to further enhance our existing apps as well as release several new apps!

We are currently developing additional risk reports for the SoftComply Risk Manager and Risk Manager Plus on Jira Server and Data Center. The Risk Matrix report has already been released and you can read more about it in the blog post below. In addition to that, we will release the Risk Table report, the Traceability report and the Risk History view over time. All of these will help better report and visualize risk management and tracking overtime. These reports will be released in Q1 2022.

We are also working on Confluence Validation app that will support automated validation of your Confluence instance - something that your Regulatory Affairs Managers and Compliance Officers will be most happy to have and use.

With Atlassian Server lifespan ending soon, we would also like to support you in migrating from Server (Risk Manager/Risk Manager Plus) to Cloud (Risk Manager). To that end, we are starting to develop automated migration tools for the Risk Manager app in Q1 2022 that will help moving your data to Cloud.

In the second half of 2022 we will also release the SoftComply Risk Manager Plus on Jira Cloud - this more complex risk management app has so far only been available on Jira Server and Data Center. With Atlassian Server life soon coming to an end, we would like to support you in having the same (or better) risk management functionality when using or migrating to Jira Cloud.

In addition to the above-mentioned developments, we are continuously improving the performance of our existing apps.

As most of you know, our backlog is based on your requests and wishes. Should you have any questions or requests for future features or apps, please don’t hesitate to let us know.
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HOW TO MANAGE SOFTWARE RISKS IN JIRA

SoftComply has developed two risk management apps on Jira: the SoftComply Risk Manager & the Risk Manager PLUS.
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On Jira Cloud, the SoftComply Risk Manager is your best choice. With the SoftComply Risk Manager app, you are able to customize your risk model/matrix and the risk table to fit your risk management process. There are embedded risk guidance templates that help you get started with FMEA or Hazard Analysis but you can also start building up your own template and use this in your next risk projects. It is easy to pull the risk data with the matrices and the table from Jira to Confluence so that you can build risk reports there for your risk management file - you can use the free Confluence extension for that.
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If you are looking for a more complex risk management app for your high risk product and use Jira Server or Data Center, best try out the SoftComply Risk Manager Plus. Risk Manager Plus extends the functionality of the Risk Manager by providing an additional risk parameter to Severity and Probability/Occurrence - that is Detectability. You can choose to calculate risks into risk classes or RPN (Risk Prioritization Numbers) as needed. In addition to Risk Management Plan and Report, there are also Risk Matrix and Risk Table reports that you can use to export them easily into different formats.

The following table illustrates the similarities and differences between the SoftComply Risk Manager vs Risk Manager Plus. Note that all the features have been described below the table. For a more detailed description, please continue reading the blog post on our website.
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RISK GUIDANCE
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Embedded Risk Management Guidance

Both the Risk Manager and the Risk Manager Plus have embedded risk management guidance within the app which can help you set up your very first risk management project. For example, if you are a medical device developer, you will need to follow ISO 14971 Hazard Analysis as a minimum. You can choose the Hazard Analysis template when you start your first risk project that will provide you the required data fields in your risk project to start with. You can further customize the project configuration and re-use that configuration in your future risk projects.

RISK CALCULATION & VISUALIZATION
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Risk Parameters

In the SoftComply Risk Manager you will have 2 risk parameters for your Risk Class calculation - Severity and Probability. You can customize the number of the Severity(IMPACT?) and Probability/Occurence levels in your risk projects as you need.

In the SoftComply Risk Manager PLUS, you can have 3 risk parameters - Severity, Probability and Detectability. With these 3 parameters you can easily manage a more complex product FMEA.
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Risk Matrices & Levels

Risk Class calculation - both SoftComply Risk Manager apps support Risk Class calculation and visualization of them in Risk Matrices - the Initial and Residual Risk Matrices. Each project has its own Initial and Residual Risk Matrices - fully customizable by the users.

Risk Prioritization Numbers - in the SoftComply Risk Manager Plus you can choose to calculate risks also in RPNs and visualize them in Risk Levels instead of Risk Matrices. RPNs are often used in FMEAs, particularly in FMEAs with Detectability parameter. Users can define their Risk Levels themselves.

RISK REPORTING
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Risk Reports in Confluence Cloud

The SoftComply Risk Manager Cloud has a free extension in Confluence that supports adding Risk Matrices and Risk Table to your Confluence pages. Using this extension will help build risk reports in real time with the data you want to visualize for risk approvals or just risk tracking.
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Risk Matrix & Risk Table Reports in Server/Data Center

In the SoftComply Risk Manager Server/Data Center and in the Risk Manager Plus, there is are additional reports called the Risk Matrix Report & the Risk Table Report. These reports pull your chosen risks into the risk matrices and risk tables and supports exporting to various formats from there.
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Risk Matrix Dashboard Item

Dashboard items provide a fantastic visualization of your data in Jira. In the SoftComply Risk Manager and in the Risk Manager Plus on Jira Server and Data Center, you can build you risk matrices dashboard item with the information about the risk project and the specific risks you want to display. Risk Matrix dashboard item provides a great visual overview of how the risk class of each risk has changed over time.
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Risk Table Dashboard Item

In the SoftComply Risk Manager and Risk Manager Plus on Jira Server and Data Center you can also build a Risk Table dashboard item with the risks of your choice in the excel like table format. You can also export this table with the layout and colours that you can see in the dashboard into the pdf.

For more details on the SoftComply Risk Manager and Risk Manager Plus features, please see our latest blog post on our website.
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UPCOMING LIVE DEMO OF SOFTCOMPLY eQMS SOLUTION ON CONFLUENCE CLOUD

Join our upcoming 30min webinar on Feb 2!

Register here for our 30min live demo where we will show you how to implement ISO13485, IEC62304, FDA 21 CFR 820 compliant Quality Management System on Confluence Cloud:
- QMS documentation with embedded guidance;
- FDA 21 CFR 11 compliant document control workflows;
- CAPA and Change Request workflows;
- Training Management workflows;
- E-signatures for approvals;
- 10min QA session.
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SOFTCOMPLY NOMINATION AT ESTONIAN STARTUP AWARDS

SoftComply was nominated as one of the Stereotype Crushers of 2021 among Estonian startups. It was a great honour to get shortlisted as one of the trendsetters in the country of digital unicorns. You can read more about the awards here.
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SOFTCOMPLY EQMS SOLUTION ON CONFLUENCE

SoftComply eQMS Solution was mentioned among other top use cases in Communardo's "Hitchhiker's Guide to Atlassian App Galaxy". You can read more about it 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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Benefits of the SoftComply Static Snapshots for Confluence Cloud:

▪ Capture and Freeze Data in Confluence
▪ Display Static Data in Confluence pages
▪ Approve Confluence pages that do not change
▪ Create Jira macros & freeze the Jira data with the Snapshot
▪ Capture and Freeze Data in Confluence
▪ Display Static Data in Confluence pages
▪ Approve Confluence pages that do not change
▪ Create Jira macros & freeze the Jira data with the Snapshot
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RiskManagerPLUS Logo

Benefits of the SoftComply Risk Manager PLUS for Jira Server & Data Center:

▪ 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:

Contact us for a demo call of the FDA 21 CFR 11 compliant eQMS Solution on Confluence Cloud.
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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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