UPDATE: In October 2018, Rina Nir, the author of this guest blog post, joined us for an ALM Works webinar on the same topic. A recording of that webinar is available on YouTube for your review and comments.

My clients at RadBee come from some of the most tightly regulated sectors — pharmaceuticals, medtech, and biotech. We lead Agile transformations that are more complex than most, because they must respect exacting compliance guidelines. I spent nine years leading the R&D for a medical devices company, so I’m unsurprised when I hear the same question from every client:

It’s a thorny matter, to be sure. I recently wrote about the unique challenges life sciences companies face during Agile adoption. Luckily, the Atlassian ecosystem is flexible enough to meet these demands. I mentioned Structure for Jira as a key element of our solutions — here I’ll go more in-depth about its role in our Agile transformations.

The Difficulty of Design Controls

Medtech companies must adhere to strict design controls — that’s the medtech-specific term for SDLC. Any medical software release must have a detailed set of documentation including design specifications, test cases, and test results. Companies must prove that they know what the software does, and they have tested it to specification.

Pharma companies face similar challenges when they roll out software to support their operations — their process is known as Computers Systems Validation (CSV).

In both medtech and pharma, everything must be documented. Everything must be traceable.

In short, traceability matrices are the nightmare of anyone who develops software in this domain.

To ensure compliance at release time, this documentation must be built and maintained throughout the development process. While Jira is wonderful at managing sprints, design control and traceability is a less natural fit. Many teams handle design control in Excel and Word, or other software specifically created for this purpose (like Rationale, for example).

Many of our clients’ teams desperately want to do design control in Jira, because developers love it so much. Having the right Jira setup can keep developers engaged and compliant — a necessity in any heavily regulated industry.

Traceability can be achieved in Jira by creating issue links, but this can leave project managers in the dark. Because the links are only visible from the issue itself, project managers won’t see the big picture without an appropriate app.

How Structure for Jira Helps

We discovered Structure for Jira in late 2017 — I only wish we had found it sooner. Project managers need to view many requirements on one screen and ensure everything has a related test case. Structure lets them do that in a familiar, spreadsheet-like view. With no need to use multiple tools, there’s much less room for error, because everything can be managed in Jira.

Purpose-built Structure views of relevant Jira issues and tasks make life much easier. The layout of Structure is very similar to a traditional traceability matrix. Because of this familiarity and convenience factor, Structure is now a standard part of our solutions for all our SDLC and CSV projects.

The most crucial power of Structure comes from its powerful automation features. We use the extend automation feature heavily, so that clients always know when a new requirement or specification is added. The ability to automatically add new items to a structure takes pressure off the project managers — they can rest easy knowing they won’t miss anything.

Our clients appreciate the interactivity of Structure. I’ve heard many people use Structure as their main view for Jira issues, because it’s easy to add issues directly, make quick edits, and see the big picture.

Need more efficient SDLC for your MedTech, BioTech, or Pharma related software? Contact RadBee to find out how Structure for Jira can help you stay compliant and make productivity gains. To learn more about Structure for Jira visit the Structure Overview page on the ALM Works website.