EN
PLStatSoft PV Process Validation application is designed for performing statistical analyses of data collected during process validation study. The program can be used to statistically assess the homogeneity and capability of validation batches to meet the quality specifications of a medicinal product and to demonstrate their equivalence. The software is validated in accordance with cGxP requirements.
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
- Assessment of the equivalence of validation batches using significance and equivalence tests
- Assessment of the probability of an OOS result
