StatSoft EM Environmental Monitoring application is designed for statistical evaluation of data collected during environmental monitoring of sterile and non-sterile forms production. The program was developed for the evaluation of microbiological, chemical and physical parameters of air, rooms, personnel and clean installations. The application is validated according to 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
- Evaluation the state of the manufacturing environment through monitoring:
- observational data
- contamination recovery rate (USP 1116)
- rare events
- Setting action (control) and alert (warning) limits, using:
- Shewhart’s control chart method
- theoretical model method
- empirical distribution method
- Evaluation the profile of microorganisms by genus and species using
- Evaluation of the frequency of causes of OOT/OOL results using
- Descriptive analysis using run chart, histogram and descriptive statistics
- Model analysis using normality, autocorrelation and trend tests/plots
- Identification of outliers with the option of removing them from the statistical analysis
- Identification of atypical trends according to Nelson’s rules
- Determination and saving of control limits used to monitor ongoing production
|
EN
PL