Self-Directed Computer System Validation Workflow for Automated Documentation
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Solution Overview
Problem
Regulated industries face time-consuming and complex processes in validating software systems due to the need for multiple expert inputs and manual generation of internationally recognized documentation, lacking efficient automation for system validation.
Innovation Solution
A self-directed computer system validation system that includes logic to provide a graphical user interface for selecting requirements, automating the selection of procedures, and generating documentation to validate the system, while identifying conflicts and dependencies, and providing step-by-step instructions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of time
If manual generation of validation documentation is used, then documentation can be tailored to specific needs, but the process is time-consuming and requires multiple expert inputs
Solution Approach 1:
The system enables self-directed validation where users independently navigate requirements, select procedures, and generate documentation without requiring multiple expert inputs. The automated system performs validation procedures and generates internationally recognized documentation deliverables, reducing time loss while maintaining customization through user-guided selection.
Solution Approach 2:
The patent replaces manual mechanical processes of documentation generation with an automated computer system. The system automatically selects procedures, executes validation tests, and generates documentation based on selected requirements, substituting manual expert work with automated logic while maintaining the ability to tailor outputs to specific needs.
2Productivity
If automated validation systems are implemented, then validation efficiency improves, but system complexity increases
Solution Approach 1:
The validation system is segmented into distinct modular components: requirement selection interface, procedure selection logic, automated validation execution engine, and documentation generation module. Each component handles a specific aspect of validation, making the overall complex system manageable and easier to implement while maintaining high productivity through automation.
3Reliability
If multiple expert inputs are required for validation, then validation thoroughness improves, but the process becomes more complex and time-consuming
Solution Approach 1:
The system incorporates feedback mechanisms where users can review generated documentation and validation results, and the system adjusts accordingly. This feedback loop ensures validation thoroughness by allowing users to verify automated outputs against their specific needs, maintaining reliability without requiring multiple expert inputs simultaneously.
Data Source
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AI summary
A system for self-directed computer system validation includes first logic to provide a graphical user interface to enable a user to select a set of selected requirements from a plurality of available requirements; second logic to select a set of procedures to satisfy the need to test against each of the requirements and document evidence of the outcomes and generate a set of documents for installing and configuring the system and test protocols including all methods and objects needed to validate the system; and third logic to provide the set of documents for installing and configuring the system and test protocols including all methods and objects needed to validate the system.