PS Product Quality Review

The module is used to develop part of the periodic Product Quality Review and/or the Ongoing Process Verification related to statistical data analysis. The module was designed for the assessment of product quality attributes, being subject to periodic trend analysis of the process.

Basic module functions:

  • Process stability and capability analysis of production batches using graphical and numerical methods
  • Analyses of data having normal distribution as well as non-normal distribution
  • Identification of outliers, with the possibility of their removal from the statistical analysis
  • Derivation and saving of control limits used to monitor the on-going production
  • Configuration of the contents of a report with a choice of a range of statistical analysis and analyses criteria
  • Generation of reports in PDF/Word, including the English version
  • Creation of standardized templates that contain configured range of statistical analysis
  • Option: storing data in the database with audit trail

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Monitoring and evaluation of product quality attributes

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