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 Manage Software Risks in Jira?

Perhaps the question we should ask first is: WHY MANAGE RISKS IN JIRA? A growing number of software product companies in the world are already using Atlassian tools and enjoying the seamless integration between project and document management with easy tracking and monitoring of their work. More and more companies are ready to abandon standalone […]

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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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How to Manage Requirements in Confluence and Jira

Requirements management in the regulated domains such as medtech, automotive or aviation has certain differences compared to the agile development. Jira Software with its easy to use backlog view and work boards suits best for managing requirements in the agile world. For the regulated domains it might be better to use Confluence in addition to […]

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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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Book Review of “Risk: Why Smart People Have Dumb Accidents”

Book review of Steve Casner’s Risk: why smart people have dumb accidents – and what we can learn from them

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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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Compliance of myBioma

The Regulatory Compliance Journey of myBioma Biome Diagnostics GmbH is an Austrian medtech start-up utilizing the genetic information of the microbiome and AI to develop medical diagnostic software for doctors. Biome Dx products utilize technologies such as next-generation sequencing, pipeline architectures and microservices. With their lifestyle product myBioma every European has the possibility to learn […]

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