FDA Foreign Inspection Planning and Scheduling System (FIPSS)
Digital Transformation of FDA Case Management System
The US heavily imports global products for its people. The FDA's purpose is safeguarding public health by assuring safety of items like food, cosmetics, drugs, and devices. The FDA's Office of Regulatory Affairs (ORA) manages inspections of foreign firms producing regulated goods. Inspections involve multiple agencies and can take 50 to 90 days, impacting timely clearance and product safety. Over 5,000 users collaborate to ensure American consumer safety by following FDA inspection processes.
During FY 2019, the FDA completed more than 3,900 inspections of foreign companies, with this figure consistently increasing. The FDA's Office of Regulatory Affairs (ORA) faced challenges due to the absence of a unified system to oversee foreign inspections across its program offices. While one office utilized a SharePoint-based pilot system for coordination, other offices relied on manual planning methods. The SharePoint system suffered from limitations in scalability, maintenance, and performance. To manage trip specifics, firm details, logistics, and budgets, users depended on multiple tools like Excel, PDFs, and emails. The variation in assignment sources for different program offices led to inefficiencies. The manual approach hampered the adept handling of intricate inspection logistics, potentially causing duplications, delays, and elevated expenses. The FDA aimed to enhance the allocation of its limited resources and budgets for foreign inspections through technological solutions, a pivotal step for upholding consumer safety and preventing unsafe products from infiltrating the US market.
The collaboration between ADG and the FDA led to the development of the Foreign Inspection Planning and Scheduling System (FIPSS), a web-based application designed to facilitate the tracking, planning, and coordination of foreign inspections. Using a human-centered design approach, ADG combined technical aspects with user-centric features to align with FDA's business goals. The application was built using cloud-native, open-source .Net and Angular technologies, utilizing a modular microservices architecture that enables adaptable changes to business logic independently.
Through a comprehensive automated CI/CD pipeline, ADG streamlined the deployment process, significantly improving efficiency and security. FIPSS's integration with other FDA applications and data repositories fostered a more collaborative ecosystem, enhancing coordination between previously disparate components. This interoperability allowed the creation of up-to-date reports within the application using FDA's chosen data visualization platform.
FIPSS was strategically designed to increase productivity, enabling the FDA to group inspections of geographically proximate factories and assign a single inspector to multiple compliance checks. The application's geographical components leveraged latitude/longitude coordinates and address geocoding for precise location identification. This approach resolved the challenges of canceled inspections due to location issues. Overall, FIPSS represents an innovative solution that enhances inspection planning, streamlines processes, and fosters collaboration within the FDA's regulatory efforts.
The FIPSS application brought significant advancements to the FDA by enhancing inspection efficiency, enabling more inspections within existing resources. Leveraging cloud-native technologies, FIPSS streamlined processes, automated development, and improved collaboration among FDA components. Key benefits included a consolidated, searchable database for inspections, reduced human errors through increased automation, and optimized travel costs by grouping geographically proximate inspections. Over 1,500 FDA ORA staff utilized FIPSS, adding 18,250 Foreign Firm Inspections and planning 835 critical trips, with 130 already completed. The application's impact was profound, driving productivity, accuracy, and collaboration across FDA operations.
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