Enhancing LIMS Master Data Management for a Global CDMO
Clarkston Consulting recently partnered with a global CDMO to enhance their LIMS master data management. Read a synopsis of the project below or download the full case study.
Download the LIMS Master Data Management Case Study Here
A Master Data Management initiative was completed in support of a leading biologics-focused Contract Development and Manufacturing Organization (CDMO) with more than 30 years of expertise in mammalian protein manufacturing and a strong global commercial presence. The organization has produced over 250 commercial batches and supported five commercial products marketed in more than 90 countries while maintaining a long-standing commitment to quality and right-first-time execution.
To continue growth, the client engaged Clarkston Consulting to provide project leadership, master data governance, and LabWare Laboratory Information Management System (LIMS) expertise to strengthen the organization’s LabWare 8 LIMS master data structure supporting clinical and commercial-scale formulations and drug substances production.
The engagement included end-to-end support across requirement definition, configuration, validation, and migration activities. Clarkston reviewed and analyzed source documentation — including Batch Production Records (BPRs), In-Process Material Specifications (IPMSs), Certificates of Analysis (COAs), test methods, and related specifications, to define detailed master data requirements. Requirements were consolidated into structured workbooks for business validation, then translated into macro-enabled configuration templates to support build activities within LabWare 8 LIMS.
Clarkston configured key master data objects across Sample Plans, Specification Types, Item Codes, Analyses, Components, Units, and Products, and supported structured deployment activities across Development, QA, and Production environments. A structured validation and migration process was executed across Development, Quality Assurance (QA), and Production environments in close coordination with the client’s business stakeholders, IT/LIMS administrators, and Quality Control teams. Additional advisory support included enhancements to Crystal Reports to align with the updated data structure, as well as recommendations to improve cross-functional visibility, requirement readiness, and scalable testing practices.
The project enabled the successful configuration of master data for 22 drug formulations and 18 drug substances, allowing active testing and commercialization. Future master data implementations are expected to be more efficient, reducing time and cost while strengthening operational scalability.
