Integrated Analysis Report for Audit Validation
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Solution Overview
Problem
Current analysis information management systems, as described in JP 6699669 B2, do not adequately facilitate audits of analysis devices, as they rely solely on final result record reports that do not sufficiently verify the validity of analysis operations.
Innovation Solution
An analysis information management device and method that register batch files for sequential analysis, along with corresponding batch analysis data and standard information for validating analysis results, enabling the creation of integrated reports that include analysis results and evaluation of validity, thereby supporting comprehensive audits.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If only final result record reports are used to present analysis results, then the report structure remains simple, but the ability to conduct thorough audits of the analysis device is insufficient
Solution Approach 1:
The patent merges the final result record report with the audit trail report into a single integrated report. This integration combines the analysis results (from final result record reports) with the operational audit information (from audit trail reports), allowing thorough audits to be conducted while presenting a unified report structure that is easier to manage and review.
2Productivity
If separate final result record reports and audit trail reports are used, then each report can be simple and focused, but the audit process becomes time-consuming and labor-intensive
Solution Approach 1:
By integrating the final result record report and audit trail report into a single document, the patent eliminates the need for auditors to review multiple separate reports. This unified approach reduces the time and labor required for audits while maintaining the simplicity of individual report sections within the integrated structure.
3Reliability
If batch analysis data and standard information are registered and processed, then the validity of analysis operations can be verified, but the system complexity increases
Solution Approach 1:
The patent implements preliminary action by pre-registering batch files that contain both the analysis procedures and the corresponding standard information (such as standard samples and expected results) in the database before actual analysis occurs. This advance preparation enables automatic verification of analysis validity during the audit process without requiring complex real-time validation systems.
Solution Approach 2:
The patent uses copying by creating a database structure that stores standardized reference data (standard samples, expected results, operational procedures) as templates. These copied standard information are then compared against actual analysis results during audits, enabling verification without requiring complex validation algorithms or real-time computational resources.
Data Source
AI summary
Selection of a batch file that causes an analysis device to analyze a sample successively is received by a receiver. Batch analysis data that represents an analysis result and corresponds to the batch file, selection of which is received, is acquired from a database device. Standard information, for verifying validity of an analysis performed by the analysis device, which corresponds to the batch file, selection of which is received, is acquired by a standard information acquirer from the database device. A report that describes an analysis result represented by the batch analysis data and an evaluation result in regard to validity of an analysis performed by the analysis device is created by a creator based on the acquired batch analysis data and the acquired standard information.