Automated R2T System for Software Validation

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Solution Overview

Problem

The existing Requirements to Test (R2T) methodologies in computer system validation are laborious and error-prone, relying on manual processes for test script development and execution, which lacks automation and efficiency.

Innovation Solution

An automated R2T system that generates and executes UI-test automation script packages using an R2T designer, engine, and automation platform, leveraging artificial intelligence for path discovery and validation template application to ensure compliance with regulatory requirements.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual processes are used for test script development and execution, then flexibility and understanding of requirements can be maintained, but the process becomes laborious and error-prone

Engineering Contradiction:
Improveaccuracy of validation processVSAvoidautomation of test script generation and execution
Core Design Contradiction:
ReliabilityVSExtent of automation

Solution Approach 1:

The patent replaces manual mechanical processes (human operators writing and executing test scripts) with an automated computer-based system that uses machine learning models and algorithms to generate and execute test scripts automatically, thereby improving reliability while increasing automation

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The system enables self-service automation where the validation system automatically generates test scripts from requirements, executes them against the software system, and produces validation reports without requiring manual intervention, reducing human error while maintaining flexibility through configurable parameters

Inventive Principle:
Principle #25Self-service

2Productivity

If automated script generation and execution is implemented, then productivity and accuracy increase, but device complexity increases

Engineering Contradiction:
Improvespeed of validation processVSAvoidcomplexity of R2T system
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent divides the complex validation system into distinct modular components including requirement parsers, machine learning models for test generation, test execution engines, and report generators. Each module performs a specific function and can be independently configured, maintained, and scaled, increasing productivity while managing complexity through modular architecture

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The R2T system is designed as a universal platform that can validate multiple different software systems across various industries by using configurable machine learning models and adaptable test templates, achieving high productivity across diverse applications without proportionally increasing system complexity

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Loss of time

If manual test script execution is performed, then human judgment and adaptability are maintained, but time consumption and human error increase

Engineering Contradiction:
Improvetime for validation processVSAvoidautomation level of testing
Core Design Contradiction:
Loss of timeVSExtent of automation

Solution Approach 1:

The system performs preliminary actions by automatically generating comprehensive test scripts from requirements documentation before execution, preparing all necessary test cases, data, and configurations in advance. This preliminary automated preparation significantly reduces the time required for actual test execution while maintaining high automation levels

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The automated system enables continuous test execution and validation without human intervention, running test scripts continuously against the software system, automatically capturing results, and generating validation reports. This continuous automated operation eliminates delays associated with manual testing while maintaining adaptability through real-time feedback loops

Inventive Principle:
Principle #20Continuity of useful action

Data Source

PatentUS12271294B2Requirements to test system and method
Publication Date: 2025.04.08 IQVIA INC
  • US12271294B2 patent drawing
  • US12271294B2 patent drawing
  • US12271294B2 patent drawing

AI summary

A requirements to test (R2T) system is implemented, which provides an automated system by which a user interface (UI)-test automation script package is generated and the generated test scripts therein are executed against software. A visualized workflow is translated into some machine-consumable formatted file. The translated workflow is utilized by an artificial intelligence driven automated R2T engine to discover paths through the workflow, a series of executable steps for the paths that detail how the software will be used, and ultimately test scripts that are generated using pre-defined validation templates. An automation platform executes the test scripts through the software associated with the workflow, which automatically captures evidence of the executed test scripts to fulfill computer system validation requirements. The R2T system provides an automated solution for test script creation and system validation to expedite the validation process and thereby streamline a software's time to market.