Automated Trace Matrix for Software Validation Status

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Solution Overview

Problem

Conventional validation technologies are inefficient in maintaining the validated status of software applications and manufacturing systems, particularly due to manual processing of change requests and difficulties in managing relationships between requirement specifications and test steps, which is time-consuming and costly in regulated life science industries.

Innovation Solution

An automated system that dynamically creates relationships between requirement specifications and test steps by extracting and linking individual requirements and test steps from documents, generating a trace matrix to identify impacted deliverables, and maintaining validation status through a change control validation summary, utilizing a processor and memory to execute operations such as file access permission control and trace matrix generation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If manual processing is used for change requests and validation deliverables, then flexibility and control are maintained, but validation efficiency is low and processing is time-consuming

Engineering Contradiction:

Improvevalidation efficiencyVSAvoidmanual processing requirement

Core Design Contradiction:

ProductivityVSExtent of automation

Solution Approach 1:

The system enables automated self-service processing of change requests by automatically extracting requirements from documents, generating traceability matrices, identifying impacted deliverables, and maintaining validation status without requiring manual intervention for each change request processing step

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The patent replaces manual mechanical processing with automated computer-based processing. The system uses software to automatically extract requirements, generate traceability matrices, identify impacted deliverables, and maintain validation status, substituting human manual operations with automated computational processes

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Loss of time

If relationships between requirement specifications and test steps are manually managed, then accuracy can be maintained, but the process becomes complex and time-consuming

Engineering Contradiction:

Improvetime for managing relationshipsVSAvoidcomplexity of managing relationships

Core Design Contradiction:

Loss of timeVSDevice complexity

Solution Approach 1:

The system performs preliminary automated extraction of requirements and test steps from documents before change requests are submitted. Traceability matrices are pre-generated and automatically updated when changes occur, eliminating the need for manual relationship management during change processing

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent introduces an automated traceability matrix generation system as an intermediary between requirement specifications and test steps. This intermediary automatically extracts, links, and maintains relationships between requirements and test steps, simplifying the management process while ensuring accuracy

Inventive Principle:

Principle #24Intermediary (Mediator)

3Reliability

If validation status is maintained through manual processes, then compliance can be monitored, but the cost and time consumption increase significantly

Engineering Contradiction:

Improvecompliance assuranceVSAvoidtime for maintaining validation status

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The system implements automated feedback mechanisms that continuously monitor validation status and automatically update traceability matrices when changes occur. The system provides real-time feedback on compliance status and automatically notifies relevant parties, ensuring continuous compliance monitoring without manual intervention

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The patent establishes continuous automated validation status maintenance through ongoing extraction, linking, and updating of traceability information. The system operates continuously to maintain validation status rather than performing periodic manual reviews, ensuring constant compliance assurance

Inventive Principle:

Principle #20Continuity of useful action

Data Source

PatentUS9720687B2Validating and maintaining respective validation status of software applications and manufacturing systems and processes

Publication Date: 2017.08.01 VALGENESIS

AI summary

Validating and maintaining respective validated status of software applications and manufacturing systems and processes is presented herein. A validation system can comprise a mapping component configured to extract, from a set of requirement specification documents, individual requirement specifications; and extract, from a set of test function documents, test steps. Further, the validation system can comprise a tracing component configured to generate a trace matrix associating the individual requirement specifications with respective test steps of the test functions or respective documents of the set of requirement specification documents. In an aspect, the validation system can enforce, via respective object linking and embedding control extensions, respective roles of authors, reviewers, and approvers of the set of requirement specification documents. In another aspect, the validation system can electronically receive and insert test results in the set of test function documents. Further, the validation system can perform automated validation of software in execution.