What is a Risk Management File?

ISO 14971:2019 defines the Risk Management file as a “set of records and other documents that are produced by risk management”. In practice, the risk management file must contain, or have reference to, the following documents: (4.2, Note 3) The policy for establishing criteria for risk acceptability. (4.4) The Risk Management Plan. (4.5) Traceability for […]

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How to Create an Organisational Risk Register with SoftComply Risk Manager?

Abstract The aim of this blog post is to guide you through the creation of an organisation-wide Risk Register with SoftComply Risk Manager. This Risk Register supports risk management across your organisation providing your team members with a list of risks that apply to a specific product or project. To achieve that, we will first […]

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Comparison of Risk Management Apps on Jira Cloud

Following our previous post where we compared the 4 top risk management apps on Jira Server, in this post we are comparing the features of the 2 most popular risk management apps on Jira Cloud. One of them is for product and project risk management (SoftComply Risk Manager) and the other for organisational risk management (Risk […]

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What are the best Risk Management Apps on Jira & how they compare to each other?

In the following post we compare the features of 4 top risk management apps on Jira Server. Comparison of risk management apps on Jira Cloud can be viewed here. There are four popular apps on Jira Server for risk management purposes. Two of them are for product risk management and the other two for project […]

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How to Set Jira Notifications for Risk Management? Must-Have Tips for Risk Managers!

As you probably know by now Jira is the most customizable issue and project tracking software on the market. It is so flexible, in fact, that sometimes a simple feature might be forgotten or some things are not always easy to find. Today we will explain and provide practical tips on how to set and […]

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How to Manage Safety-Critical Product Risks in Jira – New Features of SoftComply Risk Manager and Risk Manager Plus

Risk management is a regulatory requirement for safety-critical products. Without compliant risk management most of these products cannot reach their users. With more and more software in safety critical products like medical devices or cars, software developers now also have to manage the risks during the development to ensure the safety of these products. The […]

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New Features of SoftComply Risk Manager and Risk Manager Plus for Jira Server Users

We are happy to introduce to you a few new features of the SoftComply Risk Manager Plus and SoftComply Risk Manager Server version. User-Enabled Sorting of Data in the Risk Management Table Data in the risk management table has so far been automatically sorted – the sorting algorithm starts from the left most column in […]

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What is FMEA?

FMEA stands for Failure Modes and Effects Analysis, it is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. From ISO 14971: “FMEA is a technique by which the consequences of an individual fault mode are systematically identified and evaluated. It is an […]

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Hazard Analysis & FME(C)A on Jira – SoftComply Risk Manager PLUS is out now!

We are happy to inform you that our Risk Management solution for Jira has gotten an upgrade for Jira Server users – the SoftComply Risk Manager Plus focusing specifically on safety-critical product/device/system risks. SoftComply Risk Manager Plus supports both Hazard Analysis as well as FME(C)A, including FME(C)A with Detectability and RPN (Risk Prioritization Number). Although […]

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