How to Create a Risk Traceability Matrix in Jira
Introduction 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 […]
Risk Management in Jira: Streamlining the Process with Powerful Tools
Risk Management in Jira In today’s fast-paced and ever-evolving business landscape, effective risk management plays a crucial role in ensuring project success and organizational stability. With the rise of digital solutions, integrating risk management practices into existing project management platforms has become a priority for many companies. In this article, we will explore how Jira, […]
How to Make your Confluence Pages Static & Compare them with the SoftComply Static Snapshots app
Introduction With the SoftComply Static Snapshots app you can capture and freeze the dynamic content of your pages in Confluence Cloud. This is something you may want to do to better measure progress over time or to make sure that the content of the pages that need to be approved will not change in the […]
Six Must-Have Atlassian Cloud Apps for the Regulated Industries
Introduction 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 […]
How to Manage Requirements in Confluence and Jira
Introduction to Requirements Management in Jira and Confluence 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 […]
How to keep your data in Confluence static?
If you have worked with Jira and Confluence, am sure you have enjoyed the integration between the two. The way you can easily pull data from Jira to Confluence by creating macros on your Confluence page with all the data from Jira that you want to display is absolutely wonderful. Now, every time you refresh […]
Risk Management Guide for a Digital Health or a Medical Device Company on Jira Cloud
Why Risk Management In the fast-paced world of medical device development, safety and quality are of utmost importance. Manufacturers must adhere to stringent regulations and standards to ensure that their devices are safe and effective for patients. One such standard that plays a crucial role in the medical device industry is ISO 14971, which focuses […]
How to Build a Risk Analysis in Jira
How to build a risk analysis in Jira with the SoftComply Risk Manager app
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 […]
3 MUST-HAVE AREAS TO CONSIDER WHEN SETTING YOUR ORGANIZATION UP ON ATLASSIAN STACK
3 things regulated industries must consider when setting up their organisations on Atlassian Jira and Confluence
