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 to support the inspection of regulated products. The Laboratory Information Management System (LIMS) which has been configured, integrated, and deployed by Dovel, harmonizes the processes into a single automated solution to manage 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.
This project is high profile within the FDA and has been given an incredibly tight timeframe for implementation. Because of the nature of the technology and the timeframe, delays in one area can easily trickle down into others. The Dovel team has worked to maintain communication across all project teams and is constantly revisiting project schedules to ensure compliance or make needed changes. The partnership between Dovel project managers and the government team has enabled this important effort to remain on track in supporting the FDA labs’ mission.