Stepping in to support Saluda Medical’s Jira validation project
Written by Rina Nir
Rina Nir
Apr 3, 2025
Case studies | Confluence | JIRA | Jira Cloud
Radbee CEO Rina Nir speaks to Mark Templeton, VP for Information Technology at Saluda Medical, to discuss his best-practice advice for Jira validation, how the organization has benefited from migrating to Atlassian Cloud, and the benefits of working with Radbee. As the developer of a novel neuromodulation platform, the teams at Saluda Medical use Jira for their product development, including for some of their quality processes. When using Jira for a quality process, Saluda Medical needs to validate Jira in consideration of the regulations and best practices that govern its industry. A process known as computer system validation (CSV).
Mark Templeton
Saluda Medical’s Jira use case
Saluda Medical had implemented a Jira issue type and workflow process to manage bugs or defects found in its medical device software. Managing defects in Jira ensures that the triage and processing of defects follow the standard operating procedure and comply with ISO 62304. Each defect is captured in a Jira ticket called “Software problem procedure” and processed through a predefined flow.
Because this proves the company is undertaking a quality process in accordance with its procedures, Jira needed to be validated. The IT team is experienced with CSV, but this was the first time they had validated any Jira process. So they engaged Radbee to help them carry out the project.
Jira validation best practice
“CSV starts with an assessment and then a plan,” explained Mark, “those are the two most critical parts of it. Assess the environment. Write your scope down. Agree what’s in and out of scope. And assess it for what parts of regulatory requirements you’re meeting – electronic records and/or signatures? What quality records are you storing? Once you do that and you put your plan together, that’s the crux of the work.”
But for the plan to be effective, he explained, you need all the right information at the outset. “It’s about getting the right inputs to make sure that plan is accurate with all the steps and deliverables you’re going to write as part of the documented evidence,” said Mark.
This list covers all the documents Saluda Medical, and organizations generally, need to create as part of a Jira validation project.
| What is it? | What’s its purpose? | Who should contribute? |
|---|---|---|
| Risk assessment | Defines the scope of the system or process that is being validated and its impact on patients’ lives or the quality system. | IT, regulatory, and business teams |
| Validation plan | Based on the level of risk that was defined, the validation plan determines which documents need to be created and by whom. | IT team |
| Standard operating procedure (or work instruction) | This describes the business process that is configured in Jira. It needs to be up to date and reflect the Jira configuration. | Business process SME |
| Requirements specifications | This is a list of requirements from the Jira configuration. | Business process SME |
| Tests | Tests to ensure that the requirements are met. For a Jira CSV, these would be manual tests. | Business process SME |
| Test report | Proof that the tests have been executed. | Business process SME |
| Jira admin handbook | Documents routine maintenance procedures for Jira. For example, access management, updates to field options, backup and restore, etc. | IT team |
| Change procedure | This describes how Jira modifications are carried out. | IT team |
Need to validate your Jira process?
Recruiting the right people
While IT drove the Jira validation project and made sure the framework was maintained and the required documents were created, they leaned on subject matter experts (SMEs) in the product development software team to write up a lot of the documentation
“We’ve done this a few times before, so we’ve got a procedure. We just sit down with each system owner and work out what needs to be done,” said Mark. “They assign their SMEs to help with the risk assessment and scope, write up the requirements, and do the validation testing. We, on the IT team, will author the assessment, the plan, and the report. We split the work between the teams.”
Managing regulatory compliance in Atlassian Cloud
Historically, Saluda Medical’s Jira Software instance was on Atlassian Server. In 2024, the business moved to Atlassian Cloud, and they haven’t looked back.
New features and lifecycle benefits
“From my IT perspective, it’s awesome. No Jira servers, no Jira administration, no Jira lifecycle management. And our business and development teams have picked up a few of the new features Atlassian has released.”
Prior to migration, the IT team was handling Jira administration, and they would have the occasional indexing or performance-related issues. But migration has meant all that’s in the past. “My firm strategy,” Mark said “is to go to cloud software as a service for the lifecycle benefits, because you’re always current. We go for cloud-native vendors as much as we can. So that’s the big goal we wanted to achieve, and we did. It’s only positive.”
Improved security
For some organizations, switching to cloud brings security concerns, but Mark says security has actually improved. “We went with Atlassian Access [now Atlassian Guard] for single sign-on. For our type of organization, with the team that I can run, every cloud vendor on the planet can do security better than me. So we have no concerns about that.”
They chose a Jira Premium plan, giving them the ability to pick where the organization’s data is stored in the world. “I don’t think the location makes a difference, but if a third party needs to know or my legal team comes to me, it’s just easier to be able to say that it’s in a particular location.”
Working with Radbee on Jira validation
The Saluda Medical team was very capable and put a lot of effort into the project. So where did Radbee add value?
For the Jira validation effort, Mark wanted an impartial second opinion to ensure the team was following the right pathway. “In principle, we knew the approach we wanted to take, but Rina helped confirm what we were doing and pointed out some areas that we could focus on that maybe we wouldn’t have thought about.
We had never been through this with Jira before. The guidance around how to look at our configuration, how to document that, and how we should manage backup and recovery were the other things that Rina provided that were important to us.
The other thing about working with Radbee is flexibility. Because we were like, ‘Let’s just start with a set number of hours and see how we go.’ I think that was useful for us. Rina provided good, very valuable guidance. And we were successful. It was fantastic – just the right level of support.”
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