SoftComply Risk Manager is now Cloud Fortified

Last week we reached an important milestone – the SoftComply Risk Manager on Jira Cloud was awarded the Cloud Fortified badge by Atlassian. The SoftComply Risk Manager is the only product risk management app on Jira and the most customisable one with Risk Management guidance, multiple views to work in and compliant Risk Reporting. To learn more about the SoftComply Risk Manager […]

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How to Create a Risk Traceability Matrix in Jira

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 matrix 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 […]

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How to Create a Risk from Jira Support Ticket?

Jira is the most flexible task management tool there is. No wonder that more than 200’000 companies across the world have found it useful. It helps software teams build their products, prioritise their backlog and manage any upcoming issues within their team. Most of these companies are using Jira Service Management to collect customer feedback […]

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Surviving Risk Management Audit with Excel: a True Account on why we Built our own Risk Management Apps on Jira

“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 […]

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How to Report Risks in Jira

When you manage your product risks in a highly regulated industry, you are well-aware that it is a business-critical and ever-lasting journey. While you may be continuously on this journey, your colleagues, managers and auditors often want to get a quick overview about it. There are those who will want to understand the statistics about […]

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How to Report Risks in Confluence

Managing your product risks in Jira is great – you can use the flexibility of Jira to add various fields to the risk table, customise the risk table and the risk matrices and filter/sort the data any which way you want when using the SoftComply Risk Manager app on Jira.  But what if you’d like to report your risks […]

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Six Must-Have Atlassian Cloud Apps for the Regulated Industries

With Atlassian’s Server end of life approaching in a few years, most companies need to decide whether to migrate to Cloud or to Data Center. Data Center may seem like a natural path to take for the larger (over 300 users) companies in the regulated domains. Nevertheless, there are some regulated industries like the medtech […]

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Risk Management Guide for a Digital Health or a Medical Device Company on Jira Cloud

Why Risk Management Compliant Risk Management is a mandatory regulatory requirement for companies in medical device and other safety-critical domains. It is a specific aspect of safety-critical system development that requires linking risks to system/software design and testing to ensure the system is safe to use. Various standalone solutions exist today for safety-critical system developers […]

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How to Build a Risk Analysis in Jira

How to build a risk analysis in Jira with the SoftComply Risk Manager app

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New in SoftComply Risk Manager on Jira Cloud

In addition to being able to apply the SoftComply Risk Manager to any Jira projects – the new feature of the Risk Manager on Jira Cloud we released in December 2020, there are another two new features we released just now. NEW RISK PROJECT CREATION WIZARD When you are creating a new risk project with […]

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How to apply SoftComply Risk Manager features to any Jira project

Wouldn’t it be cool to keep everything in Jira – your backlog, your test cases and your risks all in Jira? Yes, but you could do that for years already. But what if all that can be done in a single Jira project? That would be truly awesome! You can now do it with the […]

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Why Decompose the Probability of Harm in two – P1 and P2

P1 and P2 No we are not talking about the early Playstation versions… ISO 14971 (2019 version, Annex C) indicates that the probability of a Harm occurring can be decomposed in two probabilities, P1 and P2, where: P1 = Probability of Hazardous situation occurring P2 = Probability of Harm occurring for a given Hazardous situation […]

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