Manufacturing Execution Systems
The software tool e-Dis PQR provides crucial insights into your processdata – and not just in a regulated environment
- Runtime statistics
- Quality-related indicators in a comparison of batches
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Do you manufacture your products in a GxP-regulated environment (e.g. pharmaceuticals, biologics, medical devices, food and beverages) and do you need qualified information about your manufacturing process and your products? Do you need to look at data from production, logistics and the laboratory in a comparative batch view? Do you want to obtain statistical analysis for your product quality review (PQR) at the click of a button? Operating as the engineering part of a worldwide chemical and health care group and based on years of collaboration with pharmaceutical experts we
have developed the software tool e-DiS PQR, which provides solutions for these tasks.
Detailed knowledge and control of production processes are prerequisites for commercial success in the chemical and pharmaceutical industry. The e-DiS PQR software, developed by Bayer Technology Services, is an excellent tool to achieve these goals. e-DiS PQR enables you to fully analyse the day-to-day production process data of your production facilities with special emphasis on requirements posed by the GxP environment. The close collaboration with pharmaceutical experts in the development makes e-DiS PQR a tool which is designed to really meet the requirements of your business.
The data generated by various sources during production can be conveniently selected and assessed (e.g. raw data from a defective sensor), then analyzed and visualized as appropriate for the information sought. With process data analysis, industrial processes can be monitored in minute detail, thus enabling weak-point analysis. The processes can then be optimized to fully exploit your plant’s potential in terms of economic performance and quality assurance.
Available functions include:
- Convenient selection of process data via pick lists
- Preconfigured reports
- Batch-specific comparison of net runtimes of batches, part recipes and operations (runtime statistics)
- Plant utilization view showing batches, part recipes, step operations
- Monitoring of process trends via comparison with the “Golden Batch”
- Product quality review (PQR) of quality-related indicators
- Individually configurable reporting options for flexible analyses by means of various plotting options and by linking graphs and individual data points using formulae
- Saving of parameterized analyses for reuse
- Statistical tools
- Tests for randomness, normal distribution, aberrant values, etc.
- Fast analysis of trends and aberrant values (Westinghouse rules)
- Control charts
- Clear and concise representation of the distribution of sets of measured values (Box / Whisker plots)
- Distribution of sets of measured values (Box/Whisker plot)
- Analysis of process data
- Grading (e.g. plausible declaration of raw data as “invalid” in the event of defective sensors)
- Audit trail
- Electronic signature under 21 CFR Part 11
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