Electronic Quality Management System for Regulated Product Compliance
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current Quality Management Systems (QMS) for regulated products are often ineffective due to their paper-based, siloed, and disjointed nature, leading to increased serious adverse event reports, as they lack connected data networks to analyze, evaluate, and monitor product risks across the product life cycle.
Innovation Solution
A system and method that manages content and business processes for quality and compliance across the value chain by linking any object within the system to any other object via bidirectional relationships, utilizing a UI like ggDSILink_Anything, to enable regulatory compliance through the product life cycle.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If paper-based quality management systems are used, then implementation simplicity is maintained, but data connectivity and risk monitoring capability deteriorate
Solution Approach 1:
The patent replaces paper-based mechanical systems with an electronic Quality Management System that uses digital databases and computer networks to store, retrieve, and connect quality data. This substitution eliminates the physical limitations of paper while maintaining system accessibility and ease of implementation through software deployment.
Solution Approach 2:
The electronic QMS is designed to serve multiple functions within a single integrated platform: storing quality data, connecting it to regulatory requirements, enabling risk monitoring, and facilitating compliance reporting. This multi-functionality consolidates previously separate processes while maintaining implementation simplicity.
2Device complexity
If paper-based quality management systems are used, then system complexity is reduced, but adverse event monitoring capability deteriorates
Solution Approach 1:
The electronic QMS implements automated feedback mechanisms that continuously monitor quality data and adverse events, comparing them against regulatory requirements and risk thresholds. The system automatically generates alerts and reports when anomalies are detected, enabling proactive risk management without requiring complex manual analysis procedures.
Solution Approach 2:
The patent introduces an electronic database and software platform as intermediaries between quality data collection and adverse event monitoring. This intermediary layer automatically processes, stores, and analyzes data, connecting disparate quality functions while maintaining system accessibility and reducing the complexity of direct manual monitoring.
3Ease of operation
If siloed quality management processes are used, then process simplicity is maintained, but regulatory compliance capability deteriorates
Solution Approach 1:
The patent merges previously siloed quality management processes into a single integrated electronic system where design controls, risk management, manufacturing quality, and regulatory compliance functions are interconnected through a common database. This integration maintains operational simplicity through unified access while enabling comprehensive regulatory compliance through interconnected data relationships.
Solution Approach 2:
The electronic QMS adds a digital dimension to quality management processes, transforming physical paper-based workflows into electronic processes that can be interconnected through software relationships. This dimensional change enables new capabilities for data connectivity and regulatory mapping without increasing operational complexity for users.
Data Source
AI summary
This present disclosure relates to a system and method to manage compliance of regulated products. The system and method for managing compliance of regulated products includes qualitative and analysis of data obtained from within a company, across many companies, and from third party data sources to determine correlation, relevance, and importance of data points, as they relate to determining quality events, possible outcomes, risks and alerts, for the products.