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 future. […]
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 […]
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 […]
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 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 […]
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
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 […]
Top 3 Features of an Electronic Document Management System for Medical Devices
As all the rest of your work has moved from manual to electronic, your Document Management System (DMS) should also be fully electronic. Preferably on the same platform you are using for the rest of your medical device development related work. For example, if your software development team is using Jira, it is only natural […]
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 […]
How to Add Page Numbers to the PDF Exports of Quality Records in Confluence
Paper-based Quality Management Systems are now (almost) a thing of the past (it’s sooo 20th century…). But in some cases, printing records and documents from the eDMS is necessary, or at least exporting them to PDF. The requirements for paper documents are the same as digital documents. But, unlike electronic formats, physical misplacement or loss […]