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Accelerating
FDA Mission Impact


For a Safer America

REI Systems' History
with the FDA

REI Systems Recently Named the 3rd Largest IT Partner of the FDA 

For over six years, we have helped the FDA ensure the safety of imported products. A few examples of our mission impact include:

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FDA Success Stories

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Digitizing a Sampling Process to Rapidly Identify Dangerous Products

The Office of Regulatory Affairs (ORA) has transformed its laboratory operations by implementing the Automated Laboratory Information System (ALIS), a cloud-based solution developed in collaboration with REI.

ALIS, which was developed in just eight months, enhances efficiency by enabling ORA analysts to conduct more tests with greater accuracy and less effort, reducing the time taken for generating work packages from hours to just a click.

Most notably, ALIS has improved the speed of delivering test results to
FDA decision-makers by 55%, greatly aiding in rapid responses to protect public health.


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How SERIO is Transforming
Field Work

The Operational & Administrative System for Import Support (OASIS) faced challenges due to its legacy technology and growing demands. ORA collaborated with REI Systems to develop SERIO, replacing OASIS.

SERIO is a scalable web/mobile application compatible with various devices. This mobile solution has revolutionized the work of FDA field staff enabling instant data collection, reducing errors, and improving record quality for regulatory actions.

SERIO increased field office efficiency by 43%, led to a 10% increase in product examinations, and a 9% rise in compliance actions, all without expanding the workforce.


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Increasing FDA Inspections with a Modern Case Management System

The FDA had a manual process for organizing and scheduling foreign inspections for various products, leading to duplicated efforts and missed or delayed site inspections.

The FDA partnered with REI to address these challenges by developing the Foreign Inspection Planning and Scheduling System (FIPSS), a cloud-native solution with a modular microservices structure.

FIPSS stands out as the FDA's first application to automate deployment from development to production, with over 90% of its testing automated, significantly boosting the efficiency and security of the software
development cycle.

Our Health IT Practice Offerings

Click to download our fact sheets

Connect with our FDA Team

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Ashique Tanveer
FDA Account Director

ashique.tanveer@reisystems.com
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Jeff Myers
Senior Director
jmyers@reisystems.com
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Monty D'Ambrosio
Senior Director, HHS

monty.dambrosio@reisystems.com
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Sid Agarwal
VP of Health Systems
sagarwal@reisystems.com
LinkedIn

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About REI Systems

Founded in 1989, REI Systems (REI) provides reliable, effective, and innovative technology solutions that advance public health missions. Our technologists and consultants are passionate about solving complex public health challenges that impact millions of lives. 

We take a Mindful Modernization® approach in delivering our solutions.  We align our health customers’ strategic objectives to measurable outcomes through people, processes, and technology.  

Contact our Health consulting experts today to find out how we can help you solve complex challenges!
Email us at info@reisystems.com.