Andrea Lundkvist’s journey with Polarion began at Boule Medical during her time at KTH. On her very first day at Boule she had an introduction to Polarion from Taipuva. Despite being new to the field, she quickly grasped the intricacies of the platform and recognized its potential to revolutionize project management.
Transitions and deeper Polarion involvement
As her career progressed, Andrea’s involvement with Polarion grew, eventually leading her to spearhead its implementation within Boule Medical. Collaborating closely with the Taipuva team, she ensured a seamless transition for all stakeholders involved.
– We began by setting up requirement management, making sure it worked well for users. Then, we addressed verification, validation, and risk management step by step to keep things simple for users. Given the strict regulations in the medical device industry, we carefully examined the software for specific purposes.
Following Boule Medical, Andrea transitioned into a role as a quality and regulatory assurance consultant in the medical device industry.
– During that time, I had the opportunity to work with IVD medical devices and combination products, gaining insights into various companies’ processes and documentation requirements. While all must comply with regulatory standards, there are diverse approaches to implementation.
Collaboration leading the way
Andrea’s path led her to Taipuva, where she’s holding the position as an ALM Consultant, currently involved in projects with Trafikförvaltningen in Stockholm, also known as SL. With 200 users and three Polarion superusers, SL experiences continuous growth. Each project in Polarion is assigned an administrator for minor adjustments and user management. Andrea puts focus on the significance of collaboration:
– We conduct user group meetings to discuss Polarion progress and identify areas for improvement. It requires a dedicated group with all necessary resources.
Additionally, Andrea discussed the pharmaceutical industry’s shift towards digital tools for traceability and documentation, predicting a similar trend in the medical device sector. She pinpointed the growing significance of knowledge and traceability in the industry, citing the increased focus on risk management in new EU regulations. With documentation consuming a substantial portion of development time, efficient management of requirements, risks, and traceability becomes crucial.
“It’s crucial to review processes early in project planning”
In the ensuing Q&A session, an attendee queried the importance of aligning workflows with tool designs versus creating custom workflows. Andrea responded how very essential it is to adapt existing processes to fit the tools functionality for optimal usability and efficiency, noting that Polarion serves various purposes in SL, from requirement management in subway development to monitoring existing tours for smooth operations, closing with an important statement:
– Introducing a project timeline can accelerate progress, but beyond that, the adoption of new tools like Polarion often makes us reassess our processes and procedures, leading to improvements. It’s crucial to review processes early in project planning to ensure alignment with the tool’s implementation, as this can enhance both implementation and efficiency when utilizing Polarion.