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Understanding Compliance: Moving from Cost to Value

Throughout the life sciences sector, the key trends of globalisation and digitalisation are providing new opportunities for growth and innovation. However, within development facilities, quality assurance, lab systems and scientific teams are feeling the impact of these transformations. Especially as their endeavors to ensure high levels of compliance meet the growing regulatory pressure within the industry

With an increasingly digital and connected lab infrastructure, failing to navigate the challenges of global regulatory requirements can be costly. As such, any compliance and validation processes must be designed to meet the needs of multiple geographies, business activities, and functions.

Taking action to identify, analyse, and reduce compliance risks requires a high level of resources and expertise. However, in a fast-paced, scientific environment, researchers are already stretched thin. This brings an added risk of slowing down productivity in even the best-run laboratories if compliance is not strategically managed.

To overcome these challenges, lab managers are increasingly turning to external partners who have expertise in qualification, requalification, risk management, and remediation. By transforming their compliance processes, scientists are then free to concentrate on research and discovery and meet the evolving demands of a more digital and connected lab. Here, we speak with Joshua McWilliams, Product Manager, GxP Validation Services at PerkinElmer Inc., to learn more about the rising need in the pharma industry for compliance expertise and support.

Hi Josh, before we dive into compliance best practices can you tell us more about how your role drives and inspires you?

Sure. I lead the GxP Validation Service team as part of PerkinElmer’s OneSource strategic services group. I’m inspired by how we collaborate closely with our clients so we can determine their unique needs and help them further their science while creating or maintaining safe and compliant processes. For me, it’s exciting to see first-hand how trends and global drivers play out in the lab and affect compliance. For example, in the late 90s to early 2000s, we saw an exciting shift towards digitising labs. However, this more online route came with new challenges and required a different level of validation. As more labs move towards advanced digitalisation and cloud-based data management, they need to look at compliance in a more collaborative and connected way and share information securely and accurately.