Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
In my role as Associate Director, Computer System Validation (CSV), I manage the day-to-day activities of our validation engineers, perform quality reviews of their deliverables, and provide CSV training for up-and-coming validation engineers. Our CSV work ensures that the computerized systems used in our industry are safe and efficacious to ensure that the patients that ultimately receive the treatment from the output of these systems get the appropriate results.
I really enjoy working with the wide variety of clients that we have, some just beginning their computer system validation journey, some with limited experience, and some with a great deal of experience. Also, the variety of the systems that we work on such as Enterprise Resource Planning (ERP) systems, laboratory instruments, clinical trial systems, Artificial Intelligence-based translation systems, and even spreadsheets keep the job interesting and always provides opportunities to learn new things about CSV.
One of the biggest challenges that our clients and the life sciences industry face today is the rapid pace of change to their computerized systems and keeping their systems in a validated state. This is especially true of cloud-based systems where vendors frequently provide bug fixes and updates adding new functionality. To address this need, we have created processes for evaluating and assessing the validation impact of these frequent changes to systems and then, when necessary, producing a new validation package to address the changes. This provides a one-stop service for our clients that enables them to maintain regulatory compliance of their systems with little impact to their internal resources and day-to-day operations.
As I'm sure that we're all well aware, many industries are rapidly adopting Artificial Intelligence (AI) and the life sciences industry is also moving in this direction. AI can provide all kinds of new insights into development and creation of new treatments for patients, but is, as you can imagine, a challenge to validate to ensure that the system produces the correct and needed results. This is a great time to be in CSV as we get to learn and develop new methods and techniques to deal with these new and very unique systems.
I think that the one thing that I'd like our clients to understand about ProPharma is the depth and breadth of our services for the life sciences industry. When it comes to supporting our clients' needs, there isn't any endeavor that they might undertake that we couldn't assist them with. We have so many experts skilled in every aspect of delivering quality life sciences solutions and I am proud to play a small part in that.