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What's New in April 2022

In this April newsletter we will provide our Risk Manager users with 2 step-by-step guides.

First tutorial is on how to automatically link your Jira Service Management issues to Risk Management. This post will provide you with two ways that you can create a Risk from a Jira support ticket automatically.

Second tutorial is for the Risk Manager and Risk Manager Plus Server and DC users on how to create a Risk Traceability Report. This article will guide you through 5 steps of setting up your Risk Traceability Report.

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There are usually two ways in which companies want to link Jira Service Management (JSM) and Risk Management to each other:

(1) Service Management issue itself is considered to be a Risk.

In this case you will want to manage risks within a Service Management Project, i.e. Risks are part of JSM projects like other customer requests).

Note: Risk managers who manage risks require access to JSM or JSM software license.

OR

(2) Service Management issue is a Cause of a Risk.

In this case you can still manage risks within your Risk Management Project but you would probably like to automatically create a risk there that already has a linked Jira support ticket as its cause.

Note: This option requires Jira automation to automatically create a new Risk in the Risk Table with a link to the JSM issue as a Cause. Jira automation rule is described in the tutorial steps.

PLEASE CONTINUTE HERE FOR THE FULL TUTORIAL ON how to set up the Jira Automation rules for automatically creating a risk with a Jira support ticket as its cause, IN OUR BLOG POST.

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Risk Traceability is a great way to get a quick overview of the completeness of risk management process and it is often used in the regulated industries. The traceability report shows the coverage of risks by mitigation and verification actions. For example, in the medical device industry, both the FDA and ISO 14971 require bi-directional traceability to be established between risks, requirements and tests.

SoftComply Risk Manager and Risk Manager Plus apps on Jira Server and Data Center can generate a Risk Traceability Report automatically for you.

Risk Traceability report is provided in the format of a two-dimensional traceability matrix displaying the link type (e.g. “is mitigated by”) and the direction (small arrow pointing to the target) between risks and other Jira issues of your choice. The matrix is fully customisable and the user can specify the risks and Jira issues to be mapped as well as the link types to be displayed.

Risk Traceability report can be viewed either in Jira Dashboard or in the custom Risk Reports view.

Please see here for the STEP BY STEP GUIDE TO GENERATING A RISK TRACEABILITY REPORT using the Risk Manager Plus app on Jira Server/Data Center. Exactly the same steps can be followed when generating the Risk Traceability report using the SoftComply Risk Manager app on Jira Server or Data Center.

To continue reading, please see the FULL TUTORIAL HERE.

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JOIN OUR RISK MANAGEMENT WEBINAR & LIVE DEMO later today

The webinar will walk you through the main features of the Risk Manager apps & the risk reporting.

The Risk Management webinar is on April 27 at 6pm CET. Register here & see you soon!

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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 eQMS Solution in Confluence Playlist,
▪ Risk Management in Jira with the SoftComply Risk Manager app video,
▪ Establishing Risk Traceability in Jira and Confluence Playlist.
Medical Device Regulations & the FDA compliant eQMS Solution in Confluence Playlist,
Risk Management in Jira with the SoftComply Risk Manager app video,
Establishing Risk Traceability in Jira and Confluence Playlist.
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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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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

For full list of features of the SoftComply Static Snapshots app, please check out the User Guide. Try it out for free for a month and/or contact us to arrange a demo, provide feedback & discuss more about the features.

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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 arrange a demo, provide feedback & discuss more about the features.

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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 arrange a demo, provide feedback & discuss more about the features.

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Benefits of the SoftComply Risk Manager for Confluence:

▪ Supports Risk Reporting on your Confluence Pages
▪ Automates Risk Plan and Risk Report in your Quality Records
▪ Risk Matrix and Risk Table report macros
▪ For Jira Cloud users
▪ Fully customizable macros for the risk project of your choice
▪ Supports JQL subfilters for pulling set of risks to reports
▪ Free extension for SoftComply Risk Manager on Jira Cloud
Supports Risk Reporting on your Confluence Pages
Automates Risk Plan and Risk Report in your Quality Records
Risk Matrix and Risk Table report macros
For Jira Cloud users
Fully customizable macros for the risk project of your choice
Supports JQL subfilters for pulling set of risks to reports
Free extension for SoftComply Risk Manager on Jira Cloud

To learn more about the SoftComply Risk Manager for Confluence, please check out the User Guide or our YouTube video tutorial. Try it out yourself and/or contact us to get a demo, provide feedback & discuss more.

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