A biopharmaceutical company, focused on immunotherapy cancer treatment, was preparing for its initial production launch under extremely tight timelines. Being in a highly regulated space, it was imperative that accurate chain of custody and sample movement be tracked and that sufficient system checks be put in place throughout the manufacturing process to ensure quality and regulatory compliance. In addition, the company needed the ability to manage and process time sensitive samples and analyze them with a quick turnaround time. The company decided to implement LabWare 7 for all laboratory data collection as well as complete inventory tracking and sample chain of custody. The implementation of the LIMS would also be counted on to provide much-needed efficiencies in the sample testing process. It was imperative that the LIMS system be available for use to support the initial production engineering runs necessary for regulatory submission.
CSols, Inc., the premier laboratory informatics consultancy, and a LabWare partner was engaged to lead the development and implementation of LabWare 7 LIMS based on our LabWare expertise, industry experience, knowledge of manufacturing and laboratory processes, regulatory expertise, and proven track record of delivering quality solutions under tight timelines.