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How RadBee can help setting your QMS on Jira and Confluence.

How RadBee can help setting your QMS on Jira and Confluence.

Building a QMS on Jira and Confluence makes sense, especially if your team already uses this platform. You may find it complicated and grueling to do it solo, so you are looking for a specialist to guide you and do some of the heavy lifting. To illustrate how we could make it more doable for you, let’s take this abstract idea into a real-world context with the story of a QA manager, Jean. Her three-step journey is typical. Step 1: Deciding It’s Time for a Change Surviving an Audit Jean heaved a sigh of relief. No major findings and only three minor issues. After two days of a grueling audit,...

The Quick Start Guide to Creating a QMS With Jira & Confluence

The Quick Start Guide to Creating a QMS With Jira & Confluence

Not everyone chooses Jira and Confluence for creating their QMS system, as they are not marketed that way. Atlassian doesn’t provide step-by-step manuals as a use case, and at first glance, it’s not intuitive.  However, many life sciences companies consider using Jira and Confluence for quality management systems for many good reasons. The question they all have is, “Where do I start?” Thanks to Cloud technology, you don’t even have to install the software. Five minutes after going to Atlassian’s website, you can have your site up and running —  without even providing a credit card.  Sounds...

How to configure Jira Projects to satisfy product managers and developers?

How to configure Jira Projects to satisfy product managers and developers?

There is nothing like that buzz of starting a new project. It’s early days, and our small team is getting the ball rolling. We have a clinical App to build, the Heart-Health App (temporary name), which will help people with managing cardiac problems. We plan to use Jira for two purposes: our development tasks and product specifications. Like this, we can create our release documentation automatically. Chad, our architect, considers the best way to configure Jira to support the two roles: product managers and developers. He has configured all the issue types we need. We will use epics,...

The recipe for agile medical device teams

The recipe for agile medical device teams

Agile medical device teams used to be rare. Back in 2011, venture capitalist Marc Andreessen declared, “software is eating the world,” setting forth a then-radical idea that software programming tools and internet-based weren’t just catalysts for countless industries — they were here to stay. A decade later, it’s safe to say the life science industry has become nearly entirely software-driven. From personal health apps to surgical robots and AI diagnostics, software developers are joining MedTech companies in droves, bringing another culture with them. The medical device industry is going...

Two Quick and Easy Ways to Do Design Reviews for Requirement Documentation

Two Quick and Easy Ways to Do Design Reviews for Requirement Documentation

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 ‘evidence for compliance’.  Luckily, the documentation process for design reviews doesn’t have to be time-consuming or complicated. There are a couple of easy ways to get the job done. To illustrate, we’ll use a fictional product manager, Julia, and the medtech company for whom she works, SmashMed Ltd. Both the company and...

How Product Managers and Development Teams Can Work In Synch when Connecting Requirements to Stories

How Product Managers and Development Teams Can Work In Synch when Connecting Requirements to Stories

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 requirement or a functional specification is processed and relates to development work on stories. So, in this post, we’ll dig into the details with a simple example that illustrates how traceability items connect to stories. By the time you finish reading, you’ll understand the process — and what team collaboration looks like in...

The Essential Guide to Live vs. Static Jira Data

The Essential Guide to Live vs. Static Jira Data

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 two broad types of lists you can create using Jira data: live and static. Once you’ve defined the criteria necessary to scope the list correctly, including which fields to use, you’re ready to choose which type of list you need — and the best tools for this critical task.  What’s the difference between live and static Jira data?...

The Ultimate Guide to Creating and Exporting Traceability Matrices in Jira

The Ultimate Guide to Creating and Exporting Traceability Matrices in Jira

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 you want to view issues not as a disconnected list but rather as an hierarchical structure; i.e. traceability matrix. Jira doesn’t make it easy or convenient to create and export traceability matrices. A large installation may easily have dozens of issue types and while these items, each have their own life cycle — from creation...

Agile Alone Doesn’t Solve SaMD (Software as Medical Device) Release Delays

Agile Alone Doesn’t Solve SaMD (Software as Medical Device) Release Delays

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 and makes iteration sound like a snap, regulatory requirements can grind the process to a halt. And what often stands in the way is release documentation. Here’s how it typically plays out: The new software is implemented and tested, ready for release in the internal teams’ eyes. All that’s left is the documentation, and how long...

Document management in Confluence Cloud

Document management in Confluence Cloud

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 involves uniquely identifying each official document, approving new versions before they become effective, removing obsolete versions, as well as some other good-governance factors. In medtech and pharma, this is also called the “controlled documents process.”  In this post, I’ll be focusing on how to get your Confluence pages...