Clarkston recently completed a Veeva eQMS Implementation project for a biopharmaceutical company. This client focuses on discovering, acquiring, developing, and commercializing therapeutic medicines designed to alleviate patient suffering from debilitating diseases with significant unmet medical need.
In late 2020, the company was moving from a paper quality management system to an electronic quality management system as they prepared for launch of their first commercial product. The organization engaged Clarkston to provide project management services for Veeva eQMS implementation of modules for change control, CAPA, deviation, laboratory investigation, and product complaints.
Clarkston worked with the organization to define and implement requirements for the system and configuration. Multiple workshops were held with key users and Subject Matter Experts to optimize the QMS processes and ensure that the Veeva system modules would work with the client’s processes. Clarkston managed an aggressive timeline for simultaneous review and development of 5 eQMS modules while managing the feedback and implementation of comments from multiple workshops and process exercise sessions for each of the modules
Clarkston also served as a key point of contact with the Veeva technical team to ensure understanding of comments and feedback so that the final configuration met the requirements of the client processes. Additionally, Clarkston identified and documented the SOPs and Work Instructions needed to ensure appropriate direction for implementation of the new systems.