Validation System Asset Management Calibration Tracking
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Solution Overview
Problem
Conventional validators lack the ability to search all studies conducted, provide asset-based reports, identify equipment due or past due for calibration, and detect prior qualification studies at risk due to calibration issues.
Innovation Solution
A system comprising a portable computer device and an automated validation system that allows for configuration file storage and transmission, enabling asset-based qualification studies, equipment calibration management, and report generation, with features for identifying calibration due dates and risk assessments.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of information
If conventional validators are used for process qualification, then basic temperature monitoring and validation can be performed, but the system lacks the capability to search all studies conducted, provide asset-based reports, identify equipment due for calibration, and detect prior qualification studies at risk
Solution Approach 1:
The patent implements a hierarchical database structure where study data, asset information, calibration records, and qualification results are nested within each other. The validator system contains embedded databases that store structured information about multiple studies, assets, and their associated calibration status, allowing comprehensive information retrieval without requiring external complex systems.
Solution Approach 2:
The patent introduces an intermediary software layer that acts as a bridge between the basic validator hardware and the complex information management requirements. This software intermediary handles database queries, generates asset-based reports, tracks calibration status, and identifies at-risk studies, thereby managing information complexity without adding physical system complexity.
2Reliability
If comprehensive asset management and calibration tracking features are added to the validation system, then the ability to identify calibration needs and assess risks is improved, but the device complexity and operational burden increase
Solution Approach 1:
The patent implements automated feedback mechanisms where the system continuously monitors calibration due dates and study qualification status. The database automatically tracks calibration status of all assets used in studies and provides real-time feedback on which studies may be at risk due to expired or upcoming calibration deadlines, eliminating the need for manual tracking and reducing operational burden.
Solution Approach 2:
The system performs preliminary actions by proactively identifying equipment that is due or past due for calibration before actual qualification studies are conducted. The database structure allows the system to pre-assess the calibration status of all assets and flag potential issues in advance, enabling preventive maintenance and avoiding study delays or compliance problems.
Data Source
AI summary
A system for qualifying a process in a facility. The system includes a validation system and a portable computer device. The validation system includes a storage device, a processing device, and one or more sensor input modules each connected to one or more sensors. The portable computer device includes a storage device and a processing device. The storage device of the portable computer device includes a database comprising configuration file for configuring the validation system to perform a qualification of the asset. The processing device of the portable computer device is configured to transmit the configuration file to the validation system for storage in the storage device thereof. The processing device of the validation system is configured to load the configuration file stored in the storage device thereof and to perform the qualification of the asset based on the loaded configuration file.