About the Client

The client provides a robust software platform for FDA Compliance Risk Assessment & Mitigation. The client serves FDA regulated industries, projecting compliance risks by leveraging current and historical 483s, recalls and warning letters, combined with an advanced Projection Algorithm to provide the site’s team with potential compliance deficiencies sorted in the order of importance, to avoid the costly consequences of incompliance. The client’s software is fully integrated with FDA CFRs for Drugs, Biologics and Devices, providing a fully aligned risk management platform.

Business Challenge

The client’s platform did not support real time compliance risk information inputs to its customers. The need was to add powerful predictive analysis capabilities and risk mitigation modules to the current platform, essential for real time inputs. The predictive analytics feature would have to leverage the significantly large database of case histories, documents, and FDA regulations, available in a structured format.

The client wanted the application to be SaaS based for easier maintenance and client servicing. The analytics features would assess the customers’ strengths and weaknesses to offer comprehensive compliance deficiencies they face.

The client sought a partner with the right blend of analytics expertise and a domain track record.

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Silicus Solution

Silicus developed the core predictive analytics features in Java, leveraging the client’s existing Oracle database. Oracle was an ideal platform to work with, due to the following features:

  • Strong partitioning and sub partitioning for faster performance
  • High customizability to suit business needs
  • Advanced optimizer to create complex data modules
  • Built-in analytical tools

The application was planned to be deployed on Amazon AWS.

The application was integrated with the FDA Freedom of Information Act (FOIA) portal, gathering compliance intelligence to avoid 483 compliance issues. The predictive analytics engine was driven by algorithms that fed off the rich data available in Oracle, including:

  • 40,000+ inspection records
  • More than 18,000 483s
  • 16,000 Recalls
  • 2,000+ FDA Inspection outcomes

Silicus implemented the client’s “Project Algorithm” developed by the practice experts. It is a unique algorithm that can identify potential risk areas and prepare the customer for any future FDA inspections by providing an exhaustive compliance deficiencies report. A highly available software module constantly feeds the latest updates on the observations, warning letters, EIR, 483s and inspections.

Silicus also developed an interactive dashboard that provides insights into:

  • Top risks by CFR section, area and quality system
  • Industry trends along with top 10 risk areas for a company

One of the key features developed in the application was “Daily View”, which displayed number of searches initiated for recall, inspection, 483s and others. It allows the user to select warning letters, EIR etc. by region, investigator, and company. A questionnaire module with pre-defined set of question pertaining to Code of Federal Regulations section was also developed and implemented in the system.

The Project tracking module developed for the application allows to follow up on activities arising from the algorithm run; thereby avoiding missing of the deadlines.

A report module was developed to generate reports related to recall, 483s, investigator information, statistic, trends and keywords.

Technologies Used

Language ASP.NET MVC4


Deployment Automation Tool
Deployment Automation Tool

Amazon AWS



Web Application Server
Web Application Server

JBoss Application Server 7



Client Benefits

More Effective Compliance Management

With the generation of different FDA related reports, the client's enterprise customer were presented with more precise and actionable intelligence to keep themselves abreast of all latest FDA trends, statistic, etc. thereby mitigating compliance risk.

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