Regulatory Compliance Assessment System Using Machine Learning
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Solution Overview
Problem
Entities in regulated industries face challenges in maintaining real-time compliance with regulatory standards due to lack of immediate visibility into emerging changes and inefficiencies in manual compliance review processes, which hinder their ability to predict and manage business risks associated with non-conformances.
Innovation Solution
A regulatory compliance assessment system that collects and analyzes data from multiple sources using machine learning methodologies to generate a risk compliance index score, enabling entities to track and monitor their compliance maturity levels and identify actions to improve their compliance position.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual compliance review processes are used, then compliance assessment can be performed, but the process is time consuming, expensive and error prone
Solution Approach 1:
The patent replaces manual compliance review processes with an automated machine learning system that collects data from multiple sources, processes it through trained models, and generates compliance assessments automatically. This substitution eliminates human error and significantly reduces the time required for compliance evaluations while maintaining or improving accuracy.
Solution Approach 2:
The system enables entities to perform self-assessment of their compliance status by automatically collecting and analyzing data from their own systems and external sources. The machine learning models provide continuous monitoring and assessment without requiring external consultants, allowing organizations to independently track and improve their compliance maturity levels.
2Loss of information
If periodic audits are conducted, then compliance status can be evaluated, but real-time compliance maturity levels cannot be understood between audits
Solution Approach 1:
The patent implements continuous compliance monitoring through automated data collection and machine learning analysis that operates continuously between periodic audits. The system continuously ingests data from multiple sources, updates compliance assessments in real-time, and maintains current visibility into compliance maturity levels, eliminating the information gap that exists during periods between traditional audits.
Solution Approach 2:
The system performs preliminary compliance assessments continuously in the background, maintaining up-to-date compliance maturity levels and identifying potential issues before they become critical problems. This allows organizations to proactively address compliance gaps rather than discovering them only during periodic audits.
3Measurement precision
If comprehensive compliance data collection is performed, then accurate compliance assessment can be achieved, but system complexity increases
Solution Approach 1:
The patent segments the compliance assessment system into distinct modular components: data collection modules that gather information from specific sources, data processing modules that clean and structure the data, machine learning model modules that analyze the processed data, and output modules that generate compliance assessments. This segmentation allows each component to be developed, maintained, and scaled independently, managing overall system complexity while enabling comprehensive data collection for accurate compliance measurement.
Data Source
AI summary
An electronic platform to measure a maturity or level of an entity in view of regulatory and business risks relating to regulatory compliance. The methods and systems can collect various data (e.g., regulatory agency reports, regulatory agency warning letters (e.g. FDA warning letters), internal and vendor company audit results, fines and settlement information, country business risks, regulatory agency product recalls, etc.) from various different data sources. The collected information is analyzed using machine learning techniques to determine a risk compliance level or score for one or more of an entity's companies, functions, control types, and locations arising from regulatory audit non-conformances. The risk compliance scores can be used to generate a risk prediction and identify one or more actions to be taken by the entity to improve or increase an associated compliance level.