StatSoft PQM Product Quality Monitoring is a software designed for performing statistical analyses of data collected during product quality review and/or on-going process verification.
The application allows:
– selection of an appropriate data analyses method for a given case,
– standardization of the performed statistical analyzes and interpretation of the results,
– automatic report generation in tabular and/or graphical form.
All you need is to enter the data and press a button to get a full report in the form of a Microsoft Word or PDF document. The report includes results of the statistical analyses and comments to facilitate the interpretation of the obtained results. Optionally, the data can be stored in a dedicated database.
The software has been validated according to cGxP requirements.
- 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
- Generation of reports in Word, e-CTD, PDF, Statistica formats
- Configuration of report content with selection of statistical analysis methods
- Creation of templates, containing the configured range of statistical analyses
- Option: saving the results to a database with audit trail