A Cloud-native Inspection Management System Increases the Efficiency of FDA-regulated Foreign Inspections

The Challenge

The US Food and Drug Administration’s (FDA) Office of Regulatory Affairs (ORA) is responsible for inspecting foreign firms and plants that manufacture or process regulated goods imported into the US. Coordinating these foreign inspection trips is a complex process involving multiple agencies and offices, and can take 50 to 90 days. Delays can prevent country clearance and leave risks unchecked.

ORA did not have an enterprise-wide solution to track foreign inspections. Instead, offices planned inspections manually using spreadsheets, PDFs, and emails, with only one program office using a pilot SharePoint-based system. Using these manual systems, the FDA struggled to manage the complex logistics of foreign inspections. Furthermore, inspections could be burdensome on manufacturers, and the potential for duplicated effort and inability to inspect high-risk sites created challenges. Inspectors sometimes faced daunting travel schedules and less optimal and costly travel routings.

These manual processes led to inefficiencies and delays. Therefore, the FDA sought an efficient digital solution to optimize its limited inspectors with finite travel and resource budgets to conduct foreign inspections.

The Approach

Agilious, under our joint venture, AgilisTEK, collaborated with the FDA to implement a product model approach to help the institution analyze and find solutions. In a product model, the focus is on consistently and iteratively providing value to the end user by addressing their needs while driving organization value.

A key component of a product model is prioritizing features that satisfy the biggest user pain points and business goals. We combined an agile estimation approach with the product model to ensure reliability, accuracy, performance, scalability, and deliver the necessary outcomes.

Additionally, we leveraged best-in-class modern software development practices by using Domain Driven Design (DDD), a microservices architecture, and an artificial intelligence (AI)-based A* routing algorithm to expedite travel planning and optimize travel itineraries.

The Solution

Agilious collaborated with the FDA to develop the Foreign Inspection Planning and Scheduling System (FIPSS) to streamline the tracking, planning, and coordination of foreign inspections.

Employed Human-Centered Design and CX

We engaged with FIPSS stakeholders to incorporate human-centered design best practices and drafted the seamless user journeys after identifying the user personas of the application users.

Leveraged Artificial Intelligence

The logistics of theFDA’s inspection trips are a monumental task. A foreign inspection trip can accommodate up to 10 firms, and organizing such a trip across multiple agencies and offices typically requires 50 to 90 days. Any delays in the planning process may hinder timely country clearance, jeopardize the successful completion of the inspection, and potentially allow imported product risks to go unaddressed.

However, those logistics have been significantly optimized through the use of a sophisticated trip routing method based on the A* (pronounced “a star”) routing algorithm. The A* routing algorithm has been used in various domains for path (travel trip) planning requirements, including AI systems for natural language processing and machine learning, to optimize decision-making processes.

Developed Cloud-Native Architecture

Agilious built a cloud-native, open-source application, built on .NET and Angular technologies, using a modular microservices architecture and DDD for flexibility and adaptability.

Increased Efficiency with Automated Testing and CI/CD DevSecOps Pipeline

The automated Continuous Integration and Continuous Delivery (CI/CD) pipeline and extensive automated testing enhanced efficiency and security within the software development process. Additionally, the integration of FIPSS with other FDA applications fostered collaboration and improved data accessibility. Now, over 90% of testing for the application is automated, making the software development process both more efficient and secure.

“FIPSS was the first FDA application to have an automated deployment moving from development and test to pre-prod and production.”

Streamlined the Planning and Scheduling Process for Higher Efficiency

We developed FIPSS to enhance the FDA’s operational efficiency by enabling the grouping of geographically close factories and assigning a single inspector to assess multiple sites, ensuring compliance with requirements across various FDA regulatory components.

The Result

Today, FIPSS continues to have an increasingly significant impact on the FDA’s ability to accomplish its mission. With the implementation of FIPSS, the FDA now conducts significantly more inspections annually using the same number of resources. Ultimately, each inspection trip managed by FIPSS contributes to reducing the risk of harmful foods, devices, or drugs injuring or sickening American consumers. The FIPSS application significantly reduces human error by increasing automation across business processes.

FIPSS has allowed the FDA to increase new digital capabilities for efficient inspections, while leveraging modern cloud-native technologies for greater accessibility and scalability. By automating the software development lifecycle through DevSecOps practices, FIPSS has also enhanced the maturity of modern software development at the FDA.