The Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA) operates several types of laboratories — microbiology, food chemistry, drug chemistry, medical devices, and forensics. ORA has 14 site labs and two mobile labs. The organization needed a solution that would mange the analytical workflow across these labs and across a project lifecycle from logging samples to assigning testing and tasks to collecting testing data to disseminating data to other systems. While the FDA has global laboratory policies and procedures, each laboratory operates individually and has supplemental policies guiding them. Dovel worked with the FDA to create a single process and then built a system that worked within that defined process.
The Laboratory Information Management System (LIMS) provides the needed capability to manage analytical workflow operations across the 825 users in ORA labs. Built on the STARLIMS platform, it supports ample accountability, data analysis, document control, workflows, report and forms generation, and other lab operations functions. The system is also able to interface directly with lab instruments and external systems.