StatSoft PQM Product Quality Monitoring application is designed for performing statistical analyses of data collected during product quality review and/or on-going process verification. The program is designed for evaluation of process stability and capability. The software is validated in accordance with cGxP requirements.
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Main functionalities:
- Saving/opening raw data in Statistica format
- Selecting statistical data analysis methods
- Generating reports in Word or PDF format
- Saving/opening complete studies along with selected settings
- Option: saving the monitoring results to a dedicated database
- Descriptive analysis using run chart, histogram and descriptive statistics
- Model analysis using normality, autocorrelation and trend tests/plots
- Stability analysis using standard as well as extended control charts
- Process capability analysis using capability indices Cp|Cpk|Pp|Ppk
- Analysis of data having both normal and non-normal distributions
- Identification of outliers with the option of removing them from the statistical analysis
- Identification of atypical trends according to Nelson’s rules
- Determination and recording of control limits used to monitor ongoing production
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