Risk Manager FAQ

The most Frequently Asked Questions about the SoftComply Risk Manager
listed below and their answers can be found in our Knowledge Portal.

Why can’t I create a new Risk Project?

There could be several reasons for this. Please have a look at your SoftComply Risk Manager configuration and answer the following questions here.

Why did my Risk Severity values change?

This is a feature of the SoftComply Risk Manager app that is related to the requirement of ISO 14971 for medical device risk management. To learn more about it and how to disable this option, please continue reading here.

Why do I see empty Risk Rows in the Risk Table?

For more information about why you may be seeing empty risk rows in the risk management table and how to avoid it, please continue reading here.

Which permissions do I need for the SoftComply Risk Manager?

Please read the Security and Permissions related questions and answers at the Risk Manager Security post.

What are the differences between the Risk Manager and Risk Manager PLUS on Jira?

There are a few differences between the Risk Manager and the Risk Manager Plus apps:

  • For Data Center Risk Manager apps comparison, please continue here to read all about them.
  • For Cloud Risk Manager apps comparison, please continue here.
What happens if my evaluation period ends?

For more information about accessing your risk data when your app evaluation period ends, please continue reading here.

How to rename locked SoftComply Risk Manager fields in Jira Server/DataCenter?

After installing the SoftComply Risk Manager app in your Jira Server or Jira Data Center, the app will create new custom fields in your Jira. Sometimes you may already have fields with the same names and may want to rename the new fields that were created. Please continue here to learn how you can rename the locked Risk Manager fields.

How is your data secured in the SoftComply Risk Manager?

For information about how data is secured, the security accreditations we hold and how has the app security been assessed, please read on about the Data Security of the SoftComply Risk Manager in our Knowledge Base.

On topics regarding Jira and Confluence, please see Atlassian Community forums.

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