Programmable Gravimetric Instrument with Rule-Based Validation
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Solution Overview
Problem
Current gravimetric measuring instruments lack the flexibility and compliance with regulatory standards for executing application programs, particularly in industries like pharmaceuticals and healthcare, where exact reproducibility and adherence to procedures are critical, due to limitations in data communication and sequential procedure execution.
Innovation Solution
A method and software system that allows for the creation and validation of application programs for gravimetric measuring instruments, enabling rule-compliant execution by linking application modules in a chronological sequence, with validation against a prescribed set of rules and adaptation for compliance, ensuring secure and documented processes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a simple RS-232 interface is used for network connection, then device complexity is reduced, but the possibilities for network applications and data communication are limited
Solution Approach 1:
The gravimetric measuring instrument is equipped with a network interface that enables multiple communication protocols and data formats, allowing the device to function with various network configurations and applications beyond simple RS-232 connections
2Reliability
If a closed sequential procedure is implemented, then compliance with standard operating procedures is ensured, but flexibility and ease of operation are reduced
Solution Approach 1:
The system allows dynamic configuration of procedure sequences where steps can be selectively activated or deactivated based on user needs and specific application requirements, while maintaining the structured framework of standard operating procedures
Solution Approach 2:
The procedure is divided into independent modular steps that can be individually configured, enabled, or disabled, allowing users to create customized workflows while maintaining compliance with required procedures
3Reliability
If data communication must be continuously installed between computer and measuring instrument, then rule-compliant documentation is achieved, but device independence and ease of operation are lost
Solution Approach 1:
The gravimetric measuring instrument contains integrated functionality to generate, store, and manage compliance documentation independently, reducing the need for continuous external computer connection while maintaining audit trail integrity
Data Source
AI summary
System with a computer for computer-aided creation of an application program, wherein the computer contains a software module, a display device, and an input device. The system has a gravimetric measuring instrument for execution of the application program, and a communications link. The computer executes the following steps:Representation, selection, and linkage of several application modules on the display device;Conversion of the selected application modules and the link into an invalidated application program;Validation of the application program by applying a prescribed rule-set, whereini) the application program is released for use if the validation is completed successfully, orii) computer-aided adaptation of the application program with renewed computer-aided validation is made possible if the validation was not successful.