Quality Assurance in Life science Umeå gets a boost from new network

Umeå's life science sector took an important step forward this spring when Umeå Biotech Incubator established a new Quality Assurance (QA) network. The network, which brings together representatives from some 15 companies, focuses on sharing experiences and strategies to deal with the increasingly complex quality requirements facing the industry.

The QA role is critical to ensuring product quality and regulatory compliance, and the network actively discusses how to engage employees best and motivate them to prioritize quality issues.

“You are often last in the process chain working as a QA Manager, and your questions can sometimes delay the process even further. It can sometimes feel lonely, but the role also gives you a unique insight into all parts of a company – from procurement to production”, explains Maria Åhman, QA Manager at Diamyd Medical and a board member of SARQA, the Swedish Association for Quality Assurance.

The network provides a platform for members to discuss common challenges and share knowledge, which is especially valuable for smaller companies with limited QA resources. Members come from different parts of the life science sector, including those working with ISO standards and GMP (Good Manufacturing Practice).

Gathers a diversity of companies
Umeå's new QA network includes participants from large organizations such as Cytiva, APL, Agrisera, and Nordic Biomarker, as well as smaller companies like UmanDiagnostics, Lipum, and Diduco. Companies that operate outside of the pharmaceutical and medtech industries are also represented.

Emelie Nordlinder works as a Quality Manager at Arevo, a Umeå-based company that creates sustainable solutions to grow plants. She welcomes the network, even though she is in a divergent industry and has different experiences from many other members.

“We all work with quality issues and everyone is faced with the challenges of, for example, documentation and how to write routines and deal with deviations. We have had interesting and insightful discussions about industry-wide problems and solutions, particularly as we have different backgrounds and experience from different companies”, says Emelie, who continues:

“We can learn from one another. It's good to have a network as a complement to discussions with your colleagues. We can also email and call each other to discuss matters”.

Select specific topics for each meeting
According to Maria Åhman, the diversity of perspectives and experiences is particularly important in an industry where quality requirements are constantly evolving and different types of regulations and standards also are approaching each other, across multiple product categories.

“It is important to be able to discuss questions at issue with each other in the network, especially when the regulations are not always unambiguous and specific. Quality assurance is about finding a balance of meeting the requirements acceptably to reproducibly deliver safe products”.

The members select specific topics to discuss at each meeting, such as documentation and quality systems. Although participants come from potentially competing companies, discussions are open and constructive.

“Everyone is keen to share their thoughts, and there is a mutual respect and understanding that the information stays within the network”, says Maria.

Aligns with UBI's regional development project
Umeå Biotech Incubator (UBI) coordinates the network, launched after a discussion with local companies who expressed fears that a lack of qualified personnel was a potential risk for continued growth in Umeå. SARQA was also positive about a local hub in Umeå – a city that had previously lacked such an initiative.

The QA Network aligns seamlessly with UBI's regional development projects, the recently completed "Life Science Engine 2.0" and the upcoming "Life Science City," both of which aim to foster growth within Umeå's thriving Life science industry.

"Quality assurance plays a crucial role in ensuring the safety and efficacy of products and services. While often overlooked, it's an indispensable aspect for success in our sector", remarks Peter Jacobsson, operations coordinator at UBI. "The QA Network not only enhances knowledge among participants but also elevates the importance of the QA function".

"This initiative marks a significant step in solidifying Umeå's position as a Life Science hub. Umeå's success stems from its open-minded approach and its 'pay-it-forward' mindset. By collectively leveraging our strengths, we create fertile ground for the Life science industry's continued expansion".