by Rina Nir | Sep 28, 2021 | Atlassian Cloud, Confluence, Electronic QMS, how-confluence-meets-the-needs-of-document-users, Jira Snapshots for Confluence
Design reviews are an integral part of managing a development project, as per the regulatory requirements of IEC 62304. Not only must each specification item be reviewed (i.e., a user need, a functional specification), but design review documentation needs to exist as... 
by Rina Nir | Sep 16, 2021 | Atlassian Cloud, Confluence, Electronic QMS, JIRA, Risk management
Following previous posts on the Radbee blog about traceability matrices and release documentation, we were asked to provide details about how to create traceable release items (i.e. Connecting Requirements to Stories). Specifically, readers wanted to know how a user... 
by Rina Nir | Sep 8, 2021 | Atlassian Cloud, Confluence, Jira Snapshots for Confluence, Risk management
Lists of Jira data are crucial aspects of your team’s workflow to keep your progress on track and your results quantifiable. From keeping projects progressing on time and on budget to acing audits, your Jira data holds the key to business growth. That said, there are... 
by Rina Nir | Sep 1, 2021 | Atlassian Cloud, Confluence, Electronic QMS, Jira Snapshots for Confluence
Jira is where your development happens, period. As time passes, your Jira use expands, and along with it, your issue types list. At first, it’s stories, bugs and tasks. Later, product risks, requirements, test cases, and test runs are added. To get the real picture... 
by Rina Nir | Aug 20, 2021 | Atlassian Cloud, Confluence, Electronic QMS, Jira Snapshots for Confluence
If your team is working on a Software as a Medical Device (SaMD), you’ll probably choose an Agile approach. Running sprints, computing velocity, grooming, retrospectives — all of that lingo becomes part of your culture. But just because the word “agile” means quick... 
by Rina Nir | Jun 30, 2021 | Atlassian Cloud, Confluence, Electronic QMS, how-confluence-meets-the-needs-of-document-users
Confluence Cloud is becoming the dominant Confluence option, which means it’s increasingly important to understand how to set the platform up for document management. Document management is one of the cornerstones of a quality management system. This typically...