Executing the Global Deployment of LabVantage LIMS for a Biopharmaceutical Company
Clarkston Consulting recently partnered with a biopharmaceutical company on a global deployment of LabVantage LIMS. Read a synopsis of the project below or download the full case study.
Download the Global Deployment of LabVantage LIMS Case Study Here
The client, a biopharmaceutical company that develops vaccines and antibody therapeutics for infectious diseases, manufactures and commercializes their own products and serves as a contract manufacturer organization (CMO) for multiple clients. The client initially engaged Clarkston to propose an IT strategy roadmap for their global implementation of an LabVantage LIMS platform for their R&D, Clinical, and Quality laboratories across 10 global sites.
Clarkston delivered a multi-phase approach based on functionality and site, followed by a detailed project plan for deployment strategy. Clarkston then transitioned into a project management leadership role, establishing global governance strategies for system configuration, validation, and master data activities, leading the business processes, requirements gathering, and site deployment activities comprising of end-user training and system adoption.
Clarkson collaborated with the client and LV project team to create both central- and site-based teams for deployment. A specialized master data team was assembled to construct, build, and manage validation activities. The initial phase was conducted by the client and implemented the Environmental Monitoring modules across the manufacturing sites. The second phase implemented functionality supporting sample management, with recording and reporting using Jasper reporting. This phase also delivered a global investigation reporting module and LV-SAP interfacing for inspection lot generation and testing approvals integrated to SAP lot release. The third phase implemented the Lab Execution System (LES) for test method procedure recording, consumable preparation, and equipment calibration; a customized Acceptable Quality Level (AQL) module; and extended environmental monitoring at the batch level. The project harmonized certificate of analysis generations from >1,000 manual templates to five global LV certificates, and the testing data management expanded to interface LV databases with JMP and Northwest Analytic software.
In all, the LV LIMS Platform was deployed over a three-year period. Despite the client experiencing a number of unavoidable site network changes that impacted resource attrition and budget, the project successfully delivered a validated LV LIMS platform that was deployed across the eight global sites and strengthened the client’s data integrity compliance. All sample creation, resulting recordings, and generation of certificates are now managed by the LV LIMS platform. With all testing data present in the LIMS database, data visualization is now possible by leveraging dashboards and reports linking to statistical tools for process capability and stability modeling. During this transformation, laboratory manual processes were eliminated, and legacy LIMS solutions were decommissioned, strengthening data integrity and compliance risks under the LV LIMS solution.
