Developing a Global LIMS Roadmap Strategy for a Biopharmaceutical Company
Clarkston Consulting recently partnered with a biopharmaceutical company on a global LIMS roadmap strategy. Read a synopsis of the project below or download the full case study.
Download the Global LIMS Roadmap Strategy Case Study Here
The client is a biopharmaceutical company that develops vaccines and antibody therapeutics for infectious diseases. The company manufactures and commercializes their products and serves as a contract manufacturer organization (CMO) for multiple clients. The client was in the process of implementing a LabVantage (LV) LIMS solution into their R&D, Clinical, and Quality laboratories. Working with LV, the client was in the process of deploying the LV Environmental Monitoring module to support harmonization efforts within their manufacturing laboratories. The client engaged Clarkston to propose an IT strategy roadmap for the full deployment of the LV functionality across R&D, Clinical, and Quality laboratories.
Clarkston approached the project by evaluating all the sites to identify their end-to-end processes, procedures, capabilities, and supporting technology of each site. From this analysis, Clarkston proposed a holistic plan for the deployment strategy over multiple phases. The first deployment was to focus on the functionality required to create samples, record results, and generate certificates of analysis. The assessment proposed opportunities to harmonize lab processes and procedures across the lab network. To assist the detail planning effort, the team created a comprehensive plan for level of effort for master data build and key areas where instrumentation interfaces and electronic laboratory notebooks were to be considered.
The success of any implementation is strengthened by proper planning and execution, while a lack of a strategy coupled with unrealistic expectations will doom the project and waste valuable resources. After generating the roadmap, Clarkston developed detailed project plans for rolling out the functionality for each site. This included the proposed project team structure for central and site-based teams, timeline and resource commitment required, and budgeting recommendations. The team presented a revised plan and approach and demonstrated feasibility with a proof-of-concept system release. As a result, the client retained Clarkston to move the project into the deployment phase.
