Challenge:

The The FDA’s mission involves enhancing and safeguarding public health. It accomplishes this by regulating a broad spectrum of products, including food, tobacco, supplements, prescription and over-the-counter drugs, vaccines, medical devices, cosmetics, and animal products. It also oversees products emitting electromagnetic radiation such as cell phones and lasers.

Operating as the criminal law enforcement wing of the FDA, the Office of Criminal Investigations (OCI) safeguards the public by probing illegal activities related to FDA-regulated products. OCI’s special agents investigate crimes, collect evidence systematically, and work toward successful prosecution. The Case Management and Administrative Resource System (CMARS) helps them document their criminal investigations.

CMARS documents criminal investigations concerning domestic and foreign organizations or manufacturers that breach FDA regulations. For instance, if an organization creates counterfeit COVID medication, an OCI user logs in to AIMS, submits a referral regarding the violation, and the system processes and approves it.

As the case evolves, the user fills out a Case Initiation Report (CIR) containing comprehensive details about the individuals, organizations, locations, and probable violations involved. Once approved, the CIR transitions into a full case, triggering a core investigation. The investigators add information, conduct interviews, and attach relevant documents to the case number, creating a consolidated case record.

However, the Oracle-based old system posed numerous difficulties. It was clumsy, hard to navigate, technologically restrictive, and lacked an intuitive design, leading to inefficiency. The system had issues with tracking related information, leading to data fragmentation and silos. It couldn’t link related elements, including multiple subjects to a case, without manual correlation.

Technical restrictions, such as a maximum character count of 2,000 for any text box, created issues when providing detailed summaries such as an arrest record. This forced users to use an external system to store text files, causing a loss of contextual information. The legacy system’s complexities and navigational challenges intensified the need for a modernized, user-friendly system.

Solution:

FDA’s trusted partner, REI Systems was tapped to modernize the criminal investigation system to better align with current needs. In search of a low-code solution, OCI selected Appian for its robust case management capabilities and Business Process Modeling (BPM) capacities, ideal for this modernization project. Being cloud-based, Appian meets non-functional requirements such as scalability and user provisioning effortlessly.

We used the old system as a base, which helped us understand the requirements regarding specific forms, actions, and approval workflows. Each type of investigation (criminal cases, investigative cases, and preliminary cases) has a different approval workflow. The type of case selected while filling out a CIR determines its approval workflow path.

REI collaborated with users and stakeholders to capture these details. During this process, we cleaned up how the system captures and uses data. While the data itself didn’t require cleaning, its capture and use within the application did.

Because the old system was primitive and used Oracle forms, we started implementing business rules to the users’ micro-interactions with the system. For example, we replaced simple number inputs for dates with more modern date picker tools. We also implemented business rules to prevent inconsistent data inputs, such as making sure an end date couldn’t precede a start date.

Capturing these requirements upfront allowed for a significantly improved system. While these enhancements could apply to any system, we had to work within the parameters of Appian’s low-code environment. This process involved understanding Appian’s UI restrictions, navigation options, and overall capabilities. This active understanding of Appian’s strengths and parameters was crucial to the modernization process.

Considerable work went into the user interface and user experience (UI/UX), adopting modern layouts and ensuring clear and easy navigation between screens. We worked with investigators, tested interfaces, took their feedback, and incorporated it into our designs, making sure business requirements and user preferences were met.

One major problem with the old system was the lack of continuity between screens, leading to a loss of context. REI wanted to make sure the users always know where they are, what they’re looking at, and the status of their tasks. The goal was to compartmentalize and organize sections further, to help users navigate through the forms and reports more efficiently. A clear hierarchy of information helped users scan pages rather than parse through individual sections. This is crucial as they could be looking at these reports for hours.

For instance, if users need to check the asset forfeiture information for several cases, they can quickly find the cases, easily locate the asset information, and digest the asset forfeiture information within seconds.

FDA has publicly declared its initiative toward technology modernization, which the agency refers to as TMAP (Technology Modernization Action Plan). This initiative promotes the adoption of a cloud-forward and low-code approach. The new system aligns with this plan as it uses Appian, and is cloud-forward because it’s native to the cloud. This means the system is hosted in the cloud rather than on a local server or computer, making it highly scalable and accessible from anywhere with an internet connection.

Anticipated Impact:

The new system was launched on September 14, 2024. REI is working toward a substantial enhancement in usability compared to the old system. Having timely access to current and past data is crucial for analyzing and predicting trends related to FDA-regulated products that may pose risks to public health.

A modernized system will:

• Improve decision-making processes.
• Enhance data management capabilities.
• Modernize business processes.
• Provide advanced reporting features.
• Reduce the use of paper.

The process of finding information, generating reports, and understanding data relationships will become much easier. OCI will achieve better data integrity by enforcing business rules. This means the system will ensure user input follows specific standards or requirements, preventing users from entering non-compliant data.

Additionally, the system will conserve users’ time because of enhancements in navigation and data management. This improvement renders the new system more efficient and user-friendly, thus boosting productivity.

In comparison to the old system, with scattered information across multiple sheets, the new Appian system brings an organized, efficient approach. With the legacy system, users had to tediously dig through data, leading to inefficiency and lost time.

The new system, however, is like a well-organized book with an index. Users can quickly reference the index, locate the page, and access the information they need. This streamlined approach keeps all activity within the Appian ecosystem, enhancing efficiency and user-friendliness.

Additional anticipated outcomes:

• Automated approvals: Rather than the previous manual process, CMARS will streamline approvals within the application. Users will submit items for approval directly, keep track of the process, and record detailed transaction information.
• Detailed information for process improvement: CMARS will provide data that can be analyzed to improve workflows. This will increase individual workers’ efficiency as well as the overall workflow.

As the system gains wider adoption, user experience will continue to improve.

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