Modernization of Application for FDA

Revolutionizing the FDA Operations through Agile and Low-Code Platforms

Background

Client

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

Problem

Legacy systems need to be modernized, workflows optimized, and operational efficiency improved for mission-critical regulatory processes.

Solution

Implementation of Appian low-code platforms, agile methodologies, and AWS cloud migration for scalable and secure solutions.

Outcome

Enhanced user experience, streamlined operations, and enhanced investigative processes for FDA personnel.

The Challenge

The FDA was struggling to maintain legacy systems like FACTS/AMS and CMARS, which were outdated and lacked modern features and usability. Legacy systems were not efficient in workflow, increased maintenance efforts, and compliance risks. Scaling applications to accommodate changing business processes, integration of advanced tools, and improving user experience were essential.

The Solution

IStream Solutions provided end-to-end IT modernization services to the FDA. It focused on low-code and cloud solutions

Modernized Applications

Migration of legacy systems to Appian-based UI, with out-of-the-box workflows, business models, and role-based security.

Agile Development

Two-week sprint cycles to develop applications, to ensure rapid iteration and user feedback.

Cloud Integration

Migrated applications to AWS, which improved scalability, reduced the cost of running operations, and facilitated data sharing through APIs.

Improved User Experience

Applied principles of Human-Centered Design to enhance interfaces and simplify processes.

Automation

Appian low-code platforms were integrated into CMARS, automating workflows and reducing manual intervention.

Key Outcomes

Efficiency

FDA investigators and supervisors now take less time to complete case reviews using Appian-based systems.

Scalability

Low-code capabilities of Appian enable smooth scaling to future business processes.

User Experience

Increased satisfaction with intuitive interfaces and streamlined workflows.

Cost Savings

Reduced maintenance requirements with modernized systems and optimized cloud usage.

Compliance

Ensured compliance with regulatory standards through robust security frameworks and 508 compliance testing.

Programs Supported:

SIRCE/IMPORTS Shared Services
ROMS (Regulatory Operations Management Business)
CMARS (Case Management and Administrative Resource System)

Key Takeaways

Agile Low-Code Transformation: Modernized legacy systems to handle more than 600 million records with Appian.
Collaborative Modernization: Worked with multiple FDA centers to address their unique challenges.
Scalable Solutions: Built applications that could adapt to changing regulations and higher workloads in the future.

Discover how IStream Solutions can help your organization achieve IT transformation.

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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