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What's New in March 2022

Devastated by the war in Ukraine and the humanitarian crisis it has caused, we are supporting companies providing humanitarian aid to people affected by the war in and around Ukraine.

In this March newsletter we will provide you with an implementation guide for the Risk Prioritisation Number (RPN) calculation in the SoftComply Risk Manager Cloud using Jira Automation rules.

We also wrote a piece of lighter reading on why we created the risk management apps on Jira in the first place after having used Excel in risk audits.

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In addition to the Atlassian’s concession program that provides financial relief to the Ukrainian customers, we at SoftComply offer our apps for free to all companies offering humanitarian aid to those affected by the war in Ukraine.

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The SoftComply Risk Manager on Jira Cloud does not include an RPN (Risk Prioritisation Number) based risk assessment method by default. The Risk Manager on Cloud comes with a two dimensional matrix instead. Only the Risk Manager Plus app on Jira Server and Data Center has an RPN risk assessment method available out-of-the-box.

Having said that, there is a fairly simple way to create your RPN score based on the values of Risk Severity and Probability in the Risk Manager on Cloud.

To do that, you will need to add an additional column that is a Text-type field column for the RPN e.g. “Score” in your Risk Table view that is updated each time the Severity or the Probability values are updated with a few simple automation rules.

To learn more about how to implement the Jira automation rules in your Risk Manager Cloud, please continue here to:

READ the step by step tutorial on how to implement RPN score calculation.

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“Ok, let’s follow a few of these risk mitigation actions down to outputs and verification activities” says the auditor.

A typical question. Anybody who’s ever been audited for risk management process, has been here dozens of times.

While I try to bring the attention of the auditor to another topic, I know a few meters away in a control room, my colleagues are scrambling through the endless Excel files, trying to find that bloody risk mitigation action.

Even if you print those gigantic Excel files on an A3, or a plotter, you just can’t read them. They are simply too big. And the page layout function of Excel is not the best.

You start rendering the last weeks prior to the audit in your head – the final push, all hands on deck, everybody rushing, hundreds of requirements, risk mitigation actions, verification protocols, deviations, reports to write, approvers that are offsite or nowhere to be found. It is not because you have been careless, it is just the reality of Every Single Project.
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To continue reading, please see the full post 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 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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