Developing a Veeva QMS Adoption and Governance Roadmap for a Commercial-Stage Biotechnology Company
Clarkston Consulting partnered with a commercial-stage biotech on a Veeva QMS adoption. Read a synopsis of the project below or download the full case study.
Download the Veeva QMS Adoption Case Study Here
The client, a commercial-stage biotechnology company focused on developing and commercializing therapies for B-cell diseases, partnered with Clarkston Consulting to assess its Veeva QMS platform, supporting processes, and user adoption approach. While Veeva Quality Management System (QMS) had successfully standardized quality processes and provided a centralized system of record, the organization recognized opportunities to improve training, user confidence, governance, and process alignment to maximize the value of its investment.
Clarkston conducted a comprehensive five-week assessment that included stakeholder interviews, user surveys, documentation reviews, and process evaluations. The engagement focused on understanding how users interacted with Veeva QMS, identifying barriers to adoption, evaluating training effectiveness, and assessing the alignment between business processes and system workflows.
While users recognized the value of Veeva QMS and appreciated the support provided by the Quality organization, many struggled with onboarding, role-specific training, process complexity, and information retrieval. Governance activities were also concentrated primarily within Quality, limiting broader business ownership and participation in enhancement decisions.
Based on these findings, Clarkston developed a practical, right-sized roadmap focused on four strategic areas: strengthening governance, simplifying processes, driving confident user adoption, and optimizing system capabilities. Recommendations included establishing a cross-functional governance model, creating a business champion network, implementing role-based onboarding and learning paths, redesigning training resources, improving search and reporting capabilities, and establishing metrics to support continuous improvement.
The engagement provided the client with a clear path forward to improve user proficiency and adoption, strengthen business ownership, and align Veeva QMS more closely with operational needs. By implementing these recommendations, the organization is positioned to enhance user experience, improve process execution, and realize greater value from its quality management system investment.
