Fostering A Quality Software Culture
By Katie Anderson, Chief Editor, Pharmaceutical Online
A focus for so many pharmaceutical manufacturers is modernizing its processes and equipment to be aligned with an advanced, pharma 4.0 strategy. According to Elaine Lowell, former quality engineer for Takeda and current consultant for Kalleid, this modernization goes beyond automation and should also include transforming culture, systems and decision-making.
One such culture in need of transformation during this technology upgrade is the quality culture. Transforming the quality culture should include the adoption of software quality engineering (SQE), but what is it, and how can it impact the quality of your products and processes?
What Is An SQE?
Lowell clarified that software quality engineering is applying quality engineering to all stages of the software and system development cycle. This can help with the development, configuration, implementation, and ultimately managing changes and releases to software and systems. I caught up with her after her presentation at the 2025 ISPE Annual Meeting & Expo, and she added, “[SQEs] are really about making sure the customer’s requirements are met. Requirements don’t just stop at system functionality. It might be we have to do this with less money but the same amount of quality.”
Implementing software quality engineering allows a company to reduce risk by increasing compliance. Quality is built into the system from the start with Quality By Design. Regulatory requirements are also met. These systems are reliable for the quality team, but also for the clinical, scientific, manufacturing, and regulatory teams. She added, “It’s about how your team works together. It is more about operational excellence.”
Fostering Collaboration
Software quality engineering can bridge quality gaps, according to Lowell. One such quality gap is staffing and productivity challenges. According to Lowell, in her former company for every one employee, nine were outsourced.
By fostering skill development across the team, these challenges are overcome. But how do you foster quality skill development in a team? It starts with a skill assessment. The organization then implements a quality learning program. This training is integrated into performance management goals, and inevitably departmental software quality engineers are established. This is all part of Lowell’s Community of Practice (CoP) for software quality engineering, which her team built.
Reducing Defects and Costs
Software quality engineering also helps reduce timeline and defect risks by recognizing defects earlier through early test cycles. Lowell established a CoP for software quality engineering to establish controls for quality but also optimize start-up costs.
The team had to assess their requirements early and establish a playbook to follow. They transferred knowledge weekly for better testing and prioritized communication over documentation. “It’s a place where people can go to share knowledge. It’s about building up that concept and allowing people to participate.”
It allowed her team to release a product two weeks ahead of schedule with no errors and no critical/major defects. The result was 66% less bugs captured across the release, an 80% reduction of bugs per user story, and a 67% increase in development velocity. Lowell also added that the team was able to reduce the cost of implementing their manufacturing facility by 20%.
Increasing Trust In New Systems
Once a SQE CoP is established, the organization should continue to comply with training, collaborate with other teams, and partner for inspection readiness to ensure an ongoing quality culture.
Lowell concluded by noting that software quality engineering is critical to the journey toward pharma 4.0 by reducing the errors and defects in adopting new technology and processes and increasing trust in the new systems.