Software developers face a number of common challenges that can cause headaches for quality assurance management. Organizations that design programs for healthcare markets, however, routinely come across additional pressures that may complicate the testing process and place additional strain on team members. When the average program fails to function properly, the result is an unsatisfied end user and potentially a drop in revenue. Faulty medical software can have far more harmful effects, inhibiting the performance of equipment and systems that are critical to providing high-quality patient care.
Due to the sensitive nature of its software, the global healthcare community has established firm guidelines regarding the performance of these applications. IEC 62304 is particularly noteworthy for QA teams, as it outlines several benchmarks that must be met during the testing process. Failing to maintain compliance with this regulation could result in substantial financial penalties that are likely to cut into a healthcare organization’s bottom line.
Canada-based BKIN Technologies, a developer of robotic solutions aimed at supporting brain function, was acutely aware of the challenges presented by IEC 62304 compliance. Despite the company’s vast wealth of scientific and technological expertise, it had difficulty ensuring that its products were staying in line with IEC 62304. A major concern among BKIN officials was determining the traceability in their QA processes to demonstrate their compliance.
BKIN’s products have the potential to greatly aid patients attempting to recuperate following a traumatic brain injury or similar ailment. Physicians could leverage the technology to enhance the quality of treatment and therapy they are able to provide. However, if the underlying software is unable to remain compliant with industry standards like IEC 62304, BKIN’s advanced tools will stay in storage.
Overcoming an ineffective management program
BKIN’s test management program at the time, Trac, was unable to provide the oversight and reporting capabilities needed to verify the QA team’s compliance with industry regulations. Beyond those concerns, software testers were unhappy with Trac’s unwieldy interface and poor navigability. Creating test cases was an arduous process, requiring QA members to devote more time and energy to these tasks.
Furthermore, Trac did not seamlessly integrate with BKIN’s JIRA platform, inhibiting its effectiveness, particularly when attempting to import various reports. The limitations of Trac forced testers to use a traditional system of copying and naming their test cases. Although this method would eventually get the job done, it was an awkward and unwieldy process. In addition to preventing team members from tracking these resources effectively, the old practice created an overflow of reports that strained BKIN’s databases, making it difficult for QA members to find relevant information when needed.
The need for greater transparency combined with Trac’s performance issues drove BKIN to pursue an alternative test management solution. Given the urgent need to meet industry regulations, company officials wanted to install a tool that would provide comprehensive traceability and oversight. They quickly found that Zephyr offered the best combination of monitoring, ease-of-use and integration features, making it an ideal solution.
“From a basic usability standpoint, Zephyr was a big step up for us,” said BKIN Technologies Senior Software Developer Duncan McLean. “Zephyr integrated very well with JIRA and had many helpful features in the way test cases could be planned and executed.”
Zephyr improves traceability, QA performance
Since implementing Zephyr, BKIN’s QA teams have been able to better track testing processes, pushing them closer to IEC 62304 compliance. With this high-quality test management system in place, BKIN Technologies can begin to realize the potential of its advanced healthcare products and eventually bring them to market.
Making the transition to Zephyr has resulted in additional benefits beyond those pertaining to industry compliance. McLean stated that the new test management system offers greater basic functionality than Trac, enhancing numerous QA processes including creating and tracking test cases. Zephyr has significantly enhanced the overall flow of BKIN’s internal QA processes, streamlining various aspects of the company’s operations. According to McLean’s estimations, Zephyr’s record-keeping features alone have reduced the amount of time he spends on these tasks by around 30 percent.
For organizations like BKIN Technologies that require immaculate traceability and reporting from their test management systems, a baseline management program is unlikely to meet their needs. As BKIN officials found, by switching to a high-quality solution such as Zephyr, companies can gain comprehensive oversight across QA processes and firmly demonstrate their compliance with industry standards and regulations. That level of oversight will enable such companies to ensure their underlying software is up to code, helping them to bring to their products to market without encountering resistance from regulatory bodies.