Automated Dossier Change Control for Regulatory Compliance
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Solution Overview
Problem
Managing pharmaceutical product regulatory compliance across multiple jurisdictions is challenging due to varying and frequently changing regulatory requirements, requiring manual retrieval and checking of documents from multiple systems in different formats, which is time-consuming and error-prone.
Innovation Solution
A dossier change control management system that automatically ingests documents from multiple sources, tracks changes, identifies gaps, and generates reports to ensure compliance, providing a standardized format for aggregated information and enabling efficient updates on regulatory submissions and document status.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual retrieval and checking of documents is used, then flexibility in handling different formats is maintained, but time consumption increases and errors occur
Solution Approach 1:
The patent replaces manual mechanical document retrieval and checking processes with an automated computer system that electronically retrieves, processes, and monitors regulatory documents. The system automatically compares documents against regulatory requirements, eliminating human error and significantly reducing time consumption while maintaining high accuracy in compliance checking.
Solution Approach 2:
The system performs self-monitoring and self-comparison of regulatory documents against stored requirements. It automatically detects changes, identifies compliance gaps, and generates reports without requiring continuous manual intervention, enabling the system to serve itself in the compliance monitoring process.
2Adaptability or versatility
If multiple systems and formats are managed manually, then comprehensive document coverage is achieved, but operational complexity increases
Solution Approach 1:
The patent implements a universal document management system that handles multiple document types, formats, and jurisdictions through a single integrated platform. The system uses standardized data structures and automated processing routines that work across different regulatory bodies and document formats, eliminating the need for separate manual management processes for each jurisdiction.
Solution Approach 2:
The system manages diversity in document formats and requirements by transforming all incoming documents into a standardized internal representation. The system adapts to different regulatory requirements by configuring parameter mappings and comparison criteria, allowing comprehensive coverage across multiple jurisdictions through parameter transformation rather than maintaining separate management systems.
3Productivity
If automated document ingestion is implemented, then time efficiency improves, but system complexity increases
Solution Approach 1:
The automated system is divided into distinct functional modules: document ingestion module, document processing module, compliance comparison module, change detection module, and reporting module. Each module handles a specific task independently, making the overall complex automation system manageable and easier to implement. The segmentation allows each component to be optimized and maintained separately.
Data Source
AI summary
A dossier change control management system periodically ingests data regarding a regulated product from multiple data stores. The dossier change control management system updates dossier data describing a dossier history for the regulated product using the received data. The dossier includes multiple documents in a standardized format and is updated based on a data mapping indicating correspondence between fields of the documents and portions of the received data. An out-of-expectation scenario for the dossier is identified based on regulatory requirements and an alert generated. A report with information about the out-of-expectation scenario is provided for display at a client device based on the alert.