StatSoft PQM Product Quality Monitoring

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.

Main functionalities: 

  • 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

Learn more with our experts! We invite you to watch the webinars:

Monitoring and evaluation of product quality attributes

Questions? Please contact our specialist team.

info@statsoftpharma.com

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