Roche Diagnostics GmbH Success Story

Bringing high-quality products to market

Part of the Roche group of companies, Roche Diagnostics GmbH provides software development services to internal teams. Employing 60 people, Roche Diagnostics plays a key role in quality assurance for the group’s point-of-care products, and supports the wider business in bringing high-quality products to market.

Dr. Andreas Staubert, Head of Operational Technologies and Data Services at Roche Diagnostics GmbH, says: “Software verification and validation activities are crucial to demonstrate compliance with good manufacturing practice during development—a key requirement for device certification. Any delays to software product delivery during the development phase of a diagnostic system can push back the launch date of the final product. For these reasons, efficient application lifecycle management [ALM] is a key goal for Roche Diagnostics.”

Looking for a more efficient approach to ALM

Since the average lifetime of Roche products is typically a decade or more, a mature ALM methodology is particularly important.

“Our team is always working on multiple software development projects in parallel, and we saw an opportunity to unlock greater ALM efficiency,” continues Dr. Staubert. “One of our objectives was to streamline the management of requirements, specifications and test cases by making it easier to visualize the relationships between all the design objects in each software project. As well as facilitating the software development process, we knew this capability would be a significant time-saver when it came to creating documentation for our regulators as part of the certification process.”

To achieve its goals, Roche Diagnostics decided to switch to a digital approach to ALM, as Dr. Staubert confirms: “We were confident that a purpose-built ALM solution would make it much easier for our teams to collaborate. For example, software testers can save significant time if all their projects are managed in a single, standardized format, as this removes the need to familiarize themselves with a different document template for each new project.”

Choosing an integrated solution

After evaluating ALM solutions from several leading vendors, Roche Diagnostics selected MatrixALM—an integrated platform for requirements, risk and test management.

Dr. Staubert says: “We targeted an ALM solution that would allow us to execute multiple software development and validation projects in a more efficient manner while reducing operational costs. MatrixALM delivered everything we were looking for, including ease of use, interoperability with our Jira project management solution, and customizable document outputs.”

Hans-Juergen Schneider at Kite IT GmbH, a subcontractor to Roche Diagnostics GmbH, adds: “Of all the solutions we considered, MatrixALM impressed us most—particularly in the way it generates documents for use in internal review processes and external certification. With MatrixALM, we can generate PDF documents in the same format as before. The crucial difference is that the new solution allows us to create these documents in a highly automated way, improving our team’s efficiency by an estimated 60%.”

Creating a single source of truth

Working with Matrix Requirements experts, Roche Diagnostics standardized on MatrixALM as its single source of truth for managing requirements, risks and test cases. Using native integration with Jira, the solution ensures that software developers and testers always have access to the latest requirements and specifications directly from MatrixALM.

Schneider says: “The Matrix Requirements team gave us excellent support with importing existing documents into the new solution, and helped us rapidly develop new tools to bring our own custom risk analysis and traceability matrix into MatrixALM. The deployment process went very smoothly, and we’ve always been very pleased with the quality and responsiveness of the support we receive.”

Boosting efficiency with instant insights

Since making the transition to MatrixALM, Roche Diagnostics has achieved its goal of enhancing the efficiency of software verification and validation.

“In the past, it was extremely difficult to ensure that user requirements specifications matched the relevant functional specifications and test cases in a single document—and linking requirements across three documents was practically impossible,” recalls Schneider. “With MatrixALM, we have a digital traceability matrix that reveals dependencies for any design object with just a couple of clicks.”

Keeping development moving smoothly

With MatrixALM, Roche Diagnostics increased visibility of possible software issues early in the development lifecycle, helping to significantly reduce rework—and associated delays to product launches—further downstream.

Dr. Staubert comments: “MatrixALM has greatly improved the transparency and traceability of requirements management at Roche Diagnostics. We are very satisfied with the ease with which we can track this vital information throughout the lifecycle, and the feedback from our users has been overwhelmingly positive.”

Tackling remote-working challenges

The Matrix Requirements solution proven particularly valuable during the COVID-19 pandemic, when lockdowns and social distancing measures across Europe meant that most Roche Diagnostics employees needed to work from home. As remote work has since then become a common practice, these Matrix Requirements digital capabilities have helped Roche Diagnostics adapt to this new way of working.

“When the pandemic struck, we were able to rapidly activate the electronic signature and archiving capabilities in MatrixALM, which allowed our quality teams to continue to perform reviews and approvals remotely,” explains Schneider. “Matrix Requirements gave us a great deal of support during the COVID-19 period, which was very helpful in mitigating the disruptive impact of the pandemic.”

Targeting future enhancements

Looking to the future, Roche Diagnostics plans to drive further efficiencies by integrating MatrixALM with its SAP document archiving solution, enabling it to upload documents automatically for long-term retention.

Dr. Staubert concludes: “Through our work with Matrix Requirements, Roche Diagnostics can execute software development and validation projects more efficiently than ever. MatrixALM allows us to better support our colleagues in the wider Roche business, enabling them to bring high-quality products to market as quickly as possible.”