Risk-Based Software Validation for Medical Devices
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Solution Overview
Problem
Current software validation processes for pharmaceutical and medical device companies are overly burdensome and inefficient, as they often require extensive testing of all software features without differentiation, leading to unnecessary resource expenditure and delays in rolling out beneficial software applications.
Innovation Solution
A computer system calculates a risk score for software application components based on intended usage and performs internal usage testing to recommend client-specific validation, focusing on features that are critical or heavily used, thereby streamlining the validation process and reducing unnecessary testing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If extensive testing of all software features is performed to ensure compliance, then software safety and compliance are improved, but validation time and resource expenditure increase significantly
Solution Approach 1:
The patent segments software features into risk categories (high, medium, low) based on their criticality to patient safety and regulatory compliance. This segmentation allows validation efforts to be focused on high-risk features while reducing testing depth for low-risk features, thereby resolving the contradiction between comprehensive safety validation and excessive time consumption.
Solution Approach 2:
The patent applies different validation intensities to different software features based on their local characteristics and risk profiles. Critical features receive rigorous validation while non-critical features receive minimal validation, eliminating the need for uniform extensive testing across all features and reducing overall validation time while maintaining safety.
2Reliability
If extensive testing of all software features is performed to ensure compliance, then software safety is improved, but resource expenditure increases significantly
Solution Approach 1:
The patent divides software features into risk-based segments that guide resource allocation. High-risk features receive disproportionate validation resources while low-risk features receive minimal resources, optimizing the distribution of testing efforts and eliminating waste on non-critical features.
Solution Approach 2:
The patent applies partial validation action to low-risk features and excessive validation action to high-risk features. This differentiated approach ensures adequate safety validation for critical features while avoiding excessive resource expenditure on non-critical features.
3Reliability
If uniform validation is applied to all software features, then compliance is ensured, but deployment speed decreases
Solution Approach 1:
The patent segments validation requirements by feature risk level, allowing simultaneous compliance with regulatory standards and accelerated deployment for low-risk features. This segmentation enables parallel processing of validation activities at different intensity levels.
Solution Approach 2:
The patent applies partial validation to low-risk features that can be deployed quickly with minimal testing, while applying excessive validation to high-risk features that require thorough compliance verification. This differential approach maintains overall compliance while enabling faster deployment of non-critical updates.
Data Source
AI summary
Embodiments are directed to performing risk-based software validation and to applying change control when upgrading a software application. In one scenario, a computer system calculates a risk score for features in a software application. This risk score indicates a relative level of risk for installing and using the software application. The computer system performs internal usage testing to determine how the software application is recommended for use, and conducts use tests to determine how a specified client uses the features of the software application as compared to the determined recommended use. Then, based on the calculated risk and the determined use of the features, the computer system provides a recommendation for the specified client indicating which portions of the software application are to undergo client-specific validation. In another scenario, a computer system applies change control when upgrading a software application from a first version to a second version.