Implementing LabVantage LIMS for a Seamless TSA Exit Strategy for a Biopharmaceutical CDMO
Clarkston Consulting recently partnered with a Contract Development and Manufacturing Organization (CDMO) client on a LIMS and TSA exit strategy. Read a synopsis of the project below or download the full case study.
Download the LIMS and TSA Exit Strategy Case Study Here
When a global biopharmaceutical and biotechnology CDMO acquired a large biologics manufacturing site, they needed to implement a new Laboratory Information Management System (LIMS) due to a Transition Service Agreement (TSA) exit. Their work in developing biologics, gene therapies, vaccines, and cell therapies required a LIMS capable of managing the complexity and scale of their operations. To ensure a smooth, compliant, and risk-free transition, they turned to Clarkston for support.
Clarkston was entrusted with managing this time-critical implementation to LabVantage LIMS, with the primary goal of hitting a TSA exit date and a viable and functional new system. The Clarkston team began conducting a deep dive into the client’s existing laboratory processes, performing a comprehensive assessment to map out a transition strategy that aligned with their business goals. Working closely with the client, Clarkston developed an implementation plan designed to ensure a seamless transition, while supporting them through every phase of the process. This included heavy configuration for new roles and job types, assisting with validation by developing test scripts and conducting dry-run testing to confirm that the new system performed as expected in real-world scenarios, while simultaneously updating Standard Operating Procedures (SOPs) and Work Instructions (WIs) to reflect the new workflows. Additionally, the Clarkston team created customized workshops and training materials to equip the client’s team with the skills and confidence needed to operate the new LIMS, ensuring a smooth handover. As a result, the client saw a successful and on-time exit from their legacy system and increased confidence in the usage of their new system.
For companies facing similar challenges, having a reliable and experienced partner in system transitions can make all the difference. At Clarkston, we have a proven track record of guiding organizations through complex LIMS migrations with minimal disruption to their operations. Our approach is tailored, strategic, and rooted in industry best practices. Whether you’re upgrading your current system or implementing a new one, we focus on optimizing processes, ensuring compliance, and preparing your teams for success.
If you’re ready to take the next step, reach out to our team. With our extensive experience and commitment to client success, we can help you navigate the complexities of your transition and elevate your operations to meet the demands of tomorrow.
