My journey in life science began in 2008, when I started a significant chapter of my career at Jansen Pharmaceuticals and MSD. During my assignments there until 2011, I improved my skills in the application of the GAMP principles ensuring compliant and validated systems within the pharmaceutical sector.
As my assignments progressed within MSD, the company adopted System Development Life Cycle (SDLC) deepening my understanding of effective computer system validation.
In 2022, I became a part of MSD’s spinoff, Organon, Organon started with in the implementation of Computer Software Assurance (CSA). At Organon, I proudly took on the role of topic lead of the CSV quality chapter for the site in Oss. This involved architecting procedures, reviewing and updating templates, and most importantly, fostering a culture of CSA awareness, training and adoption on site.
One of the hallmarks of my journey has been my role in advocating for CSA. I have worked diligently to train individuals and dispel skepticism, highlighting the transformative potential of CSA in ensuring patient safety and minimizing risks. As MSD prepared for its spinoff, my conviction in CSA’s ability to drive risk assessments aligned with patient safety became even more evident. By streamlining validation processes and harnessing the power of CSA, we achieved not only enhanced efficiency but also substantial cost savings.
While the world of validation may still involve paper-based test protocols, the introduction of CSA has ushered in a new era of streamlined, cost-effective validation practices. With a focus on risk assessment and patient safety impact CSA can master the paperless systems currently on the market.