SoftComply Risk Manager for Basic Product Risk Management

Professional, easily configurable, intuitive, and very relevant to Risk Management. Would appreciate some additional functionality - when adding columns, need to include a <List> field type; also essential is being able to access the awesome SoftComply-specific fields in dashboard gadgets; really fabulous would be a dashboard gadget that illustrates the Risk Matrix. In the meantime, this is probably the better of Risk Management add-ins for JIRA.

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  SoftComply

  Thank you for your feedback, Angela! We are delighted to hear that you found the SoftComply Risk Manager useful for you.

  We have now implemented the features you have asked. Namely, we have added additional column types to the risk table that allow you to capture different types of data about your risks.

  In addition to text areas for longer descriptions, we have also added "SingleSelect" and "MultiSelect" fields that are often used to highlight the subsystem the risks are originating from; "Links" that are used to link to any other Jira Issue or an ordinary URL; "user picker" for assigning creator or mitigator of the risk; "date" for creation or mitigation; your already existing Custom Fields; etc.

  All those fields are also searchable. In other words, you can use Jira search queries to get relevant information e.g. “Please provide all risks with harm “Some harm value”, “Provide all risks with Probability value “Probable” and Severity value “Severe””, etc. Thereafter you can use these results to display the information on Jira dashboards and/or send results periodically to your email!

  You can also generate a Jira dashboard gadget of the Risk Matrix for either the initial risk values or the residual (post mitigation) risk values or both. You can easily move from risks in the dashboard back to the risk table to view more details as needed.

  There is also an extension of the app in Confluence with which you can easily create risk reports, i.e. you can pull the Risk Matrices or the Risk Table of any existing Risk Project onto your Confluence pages.

  - Kind regards, SoftComply Team

Overdue, highly useful, risk management add on for medical device software (and hardware) development to the ISO 14971 standard for those using JIRA and Confluence. I think this would also be suitable for those doing safety critical software development in other engineering domains. The traceability features are great, giving the ability to trace risk control implementation and mitigation. The automated risk management plan and risk management report generation into Confluence is also a great feature, this should speed up our risk documentation. The choice of risk matrices and the ability to define risk levels is useful too. One feature that really stood out was the risk-line duplication tool, this helps speed up risk assessments significantly.

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  SoftComply

  Thank you, Tom, for your positive review! We are happy to hear that our product provides you the support you were looking for in managing your medical device risks! - SoftComply Team

We are currently using Risk Manager for multiple SaMD projects compliant with 13485 and 14971. Integrating the risks directly in Jira where our teams are already working greatly increases risk visibility, and allows our risk management processes to be folded seamlessly into our agile workflow, with iterative risk reviews and easy to generate documentation when it's time to build the DHF. Features like automatic risk scoring based on a customized matrix, harm-severity lock, and traceability to other work items in jira using issue links really set this addon apart from the obligatory risk spreadsheets. Since we're also tracking all of our requirements and testing in Jira, everything can be in one place, and linked together, making traceability easy, dynamic, and finalizing our documentation is much faster, allowing us to get from development to submission in less time.

This Risk Manager free version is useless as you can not make any modification. The paid version is too expensive. It is better to use another free version.

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  SoftComply

  Hi Michael,
  
  The free tier of the Risk Manager works exactly like the higher tiers - in both of them you can make modifications.
  We are happy to demo the features of the app to you but in the meantime please check out the product documentation and please do not forget to review the permissions needed to modify the risk models and tables!
  
  Looking forward to talking to you soon,

  Marion/SoftComply

If you have to manage risks for your products or processes, you will properly have tried to use a big Excel table. And you properly hated it… The SoftComply Risk Manager is, despite some potential for improving the UI, a far better solution. And since every risk is also a Jira issue, it is quite easy to link it with your development tickets. If you have to or want to manage risks for your products or processes, and you are already using Jira, we from Skinuvita strongly recommend that you give the SoftComply Risk Manager a chance.