Labs within the Food and Drug Administration (FDA) 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 and the FDA needed to standardize business processes to create a single, compliant, automated platform, the Laboratory Information Management System (LIMS).
Dovel leveraged significant subject matter expertise and domain depth to address the needs of both the LIMS business owners and end-users. Through Joint Application Development (JAD) sessions, the Dovel team collected information on all of the unique workflows and processes. We identified best practices and implemented them in the technology solution that is now being used. While the overarching objective was harmonization, site specific or process specific needs were accommodated through specific configurations or workflows within the system.
The LIMS solution enabled FDA regulatory and scientific staff to improve their ability to identify, effectively analyze, and evaluate any and all products regulated by the FDA that require laboratory analysis within a common digital system.