Author: Aswini Balasubramanian
The Food and Drug Administration (FDA) regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices. The FDA’s Office of Regulatory Affairs (ORA) inspects regulated products and manufacturers, conducts sample analyses of regulated products, and reviews imported products offered for entry into the U.S.
ORA’s laboratories play a major role in protecting consumers from unsafe, ineffective, and mislabeled products. They provide a scientific base to support ORA enforcement and regulatory activity. The laboratories test thousands of product samples annually.
Most of the sample and regulatory analysis data had been manually compiled into a cumbersome paper-based report. The reports were then uploaded to a Compliance Management System (CMS) and shared with two other large FDA databases.
ORA was ready to start its journey to the cloud and incorporate automation for collecting, processing, sharing, and compliance of analysis data to modernize field office operations and information sharing across the agency. ORA developed the Automated Laboratory Information System (ALIS) solution, which aligns with FDA’s goals to modernize field office operations and information sharing across the agency and move solutions into a cloud-native environment.
To build ALIS, ORA partnered with REI Systems. ALIS was developed using clear goals, cloud-native and emerging technologies, human-centered design, Agile and DevOps methodologies, and microservices architecture.
Clear Goals for Modernization. ORA defined three purposes for which it sought to modernize ALIS:
• Increase the speed, improve accuracy, and reduce the effort to aggregate data gathered from multiple laboratory locations.
• Move to more secure, reliable, and efficient cloud hosting, away from on-premise infrastructure.
• Reduce IT development and operations/maintenance costs by transitioning to modern technologies like microservices modules that can be incrementally upgraded, and a DevSecOps platform that helps speed future innovation.
Cloud Native and Emerging Technologies. ALIS’s cloud-native nature helped ORA focus on operational and hosting efficiency, security, and increased coordination across many FDA laboratories in dispersed geographies. It allowed ORA to integrate important security tools efficiently and sped the ability to obtain FEDRAMP certification and Authorization to Operate (ATO).
AWS X-Ray, an emerging AI technology, collects data about requests that ALIS application serves and provides tools to view, filter, and gain insights into that data to identify issues and opportunities for optimization. In the future, ORA also plans to integrate into ALIS a more comprehensive range of artificial intelligence and predictive analytic uses that will help it better address the risks and threats that the FDA wants the ORA laboratories to be able to predict and target.
Human-Centered Design. Before any code was written, a CX team conducted product research via multiple interviews with what would be the systems’ end users and stakeholders, including FDA’s staff, partner agencies, members of regulated industries, other third parties (media, academia, watchdogs, etc.), nefarious characters (e.g., persons who hope to harm Americans by contaminating our food supply) to document the product user requirements. The team then created user personas, user stories, and storyboards to help the UX designers create the specifications for an easy-to-use and intuitive application.
Agile and DevOps Delivery Framework. An agile framework was applied to build the application’s business functionality incrementally. A DevOps pipeline was established to leverage automation and continuous integration and deployment (CI/CD) of capabilities. The team used blue-green deployments so the release of capabilities could happen at any time of the day without interruption of service.
Microservice Architecture. ALIS is a microservice-based application with a dedicated database. The architecture is composed of small independent functions that make it easier to scale and faster to develop new features. The microservices also allowed for easy integration with other third-party systems for interoperability. The cloud-native orientation enables the applicate to scale with demand and provides a large storage capacity for data.
ALIS has made test results available 55% faster (two days versus five days). A user said, “The ability to generate work packages in a click of a button is great. It took hours before to do this manually.”
Since 2022, ALIS has helped the FDA aggregate the results of sample tests from multiple labs across the country, enabling FDA to better detect counterfeit, hazardous, and mislabeled products. Because ALIS has been so successful, ORA plans to build it into a one-stop shop for all sample-related programs.
ALIS is a FedHealthIT 2023 Disruptive Tech Program Award Winner!
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