The 14 labs within the Food and Drug Administration (FDA) Office of Regulatory Affairs (ORA) that are responsible for ongoing inspection of regulated products in the U.S. relied on a primarily paper-based process to record sample information and analysis information. This process varied across all of the labs. The FDA needed to standardize business processes to create a single, compliant, automated platform, the Laboratory Information Management System (LIMS). The idea of a shared platform was scary to many users, as there was a prevalent feeling in the research community that each groups needs are unique, and no one system could meet everyone’s need. Through Joint Application Development (JAD) sessions, the Dovel team was able to collect information on all of the unique workflows and processes. Best practices were identified and implemented in the technology solution that will be used by over 825 users. While the overarching objective is harmonization, site specific or process specific needs are being accommodated through specific configurations or workflows within the system.
The LIMS solution platform was rolled out to two FDA microbiology labs in January 2015 and will be implemented along with end-to-end analytical tests at the remaining microbiology labs throughout the remainder of 2015. 2016 will see the deployment of additional functionality across more disciplines.