FDA SIRCE

Revolutionizing Regulatory Oversight: A Digital Transformation for FDA Compliance

Background

Client

Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA)

Problem

The FDA’s ORA legacy systems for inspections, recalls, compliance, and enforcement were outdated, inefficient, and costly. SIRCE applications lacked modern usability, scalability, and integration.

Solution

IStream Solutions used modern web technologies, Agile development, and cloud infrastructure to streamline FDA operations. The solution featured HCD, AWS migration, and microservices for improved usability, scalability, and compliance.

Outcome

Modernized FDA systems improved efficiency, scalability, and user experience while reducing costs. Cloud migration and automation ensured compliance, security, and long-term adaptability.

The Challenge

FDA ORA SIRCE applications, including ALIS, eNspect, SERIO, PNS, and LMS, were outdated, inefficient, and redundant. To enhance compliance, security, and scalability, modernization efforts focused on cloud migration, system integration, and Human-Centered Design (HCD) for improved efficiency and user experience.

Automated Laboratory Information System (ALIS)
Electronic Inspections (eNspect)
System for Entry Review and Import Operations (SERIO)
Prior Notice System (PNS)
Laboratory Management System (LMS)

were outdated and required modernization to:

Eliminate redundancy across multiple systems.
Enhance regulatory compliance and security.
Scale applications for future business processes.
Migrate to cloud-based infrastructure for better efficiency.
Improve the user experience using Human-Centered Design (HCD).

The Solution

IStream Solutions provided end-to-end modernization of FDA SIRCE applications, focusing on agility, automation, and cloud computing.

Modernized Applications

Migration of legacy systems to a microservices-based architecture using Java 17, Angular 15, and AWS technologies.
Standardized system configurations, eliminating integration defects.
Transformed the UI with Angular and HCD approaches to improve the customer experience (CX).

Agile Development

Implemented Agile DevSecOps methodology with two-week sprint cycles for continuous development and stakeholder feedback.
Developed applications with low-code and no-code platforms (Appian, Salesforce) to accelerate development and reduce costs.

Cloud Integration

Migrated applications to AWS cloud, enhancing scalability, security, and cost efficiency.
Implemented REST API-based microservices for seamless data exchange between FDA systems.
Enhanced authentication and security using Single Sign-On (SSO) and Spring Boot Framework.

Improved User Experience

Human-Centered Design (HCD) principles improved UI/UX, making applications more user-friendly.
Compliance with Section 508 and WCAG ensured accessibility for all users.
Modular UI components made maintenance easier and system upgrades more efficient.

Automation

Developed automated workflows in SIRCE applications, reducing manual intervention.
Automated data synchronization using Spring Scheduler and Spring Boot Framework.
Integrated AI-powered data processing to ensure faster and more accurate regulatory reviews.

Key Outcomes

Efficiency

FDA investigators and supervisors now complete case reviews faster using modernized applications.
Reduced manual processing, improving overall operational efficiency.

Scalability

Microservices-based architecture enables seamless expansion of applications to support future business needs.
Cloud-based infrastructure allows for greater flexibility and security.

User Experience

Enhanced UI/UX design led to higher user satisfaction and improved adoption of FDA systems.
Modernized interfaces reduced training time for new users.

Cost Savings

Migrating to AWS cloud reduced maintenance costs and operational expenses.
Automated workflows lowered dependency on manual processes, saving time and resources.

Compliance

Ensured compliance with regulatory standards using robust security frameworks.
508 compliance testing improved accessibility for all FDA personnel.

Key Takeaways

Agile & Low-Code Transformation: Modernized legacy FDA systems using low-code platforms like Appian, making them more scalable and efficient.
Collaborative Modernization: Partnered with multiple FDA centers to address unique regulatory challenges.
Scalable Solutions: Built future-proof applications that adapt to evolving regulations and higher workloads.
Enhanced Security: Implemented advanced authentication and secure data processing protocols.

Conclusion

Through Agile methodologies, cloud integration, and Human-Centered Design, IStream Solutions successfully transformed the FDA SIRCE applications, resulting in greater efficiency, cost savings, and compliance improvements. This modernized infrastructure enables faster regulatory processes, enhanced user experience, and long-term scalability for FDA operations.

Technologies Used

AWS Cloud Services, Java 17 & Spring Boot, Angular 15 & ReactJS, Kafka & Redis, CI/CD Pipelines

Discover how modernizing systems can drive efficiency, scalability, and compliance.

IStream Solutions collaborates with trusted partners and serves diverse clients with exceptional IT solutions. Together, we lead transformation, adaptability, and long-term impact across industries.

Building Lasting Value, Accelerating Digital Transformation Across Industries.

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