PS Process Validation

The module is used to develop part of the process validation report related to statistical data analysis. The module was designed for the assessment of product quality attributes, being subject to validation study.

Basic module functions:

  • Process stability and capability analysis of validation batches using graphical and numerical methods
  • Evaluation of equivalency between validation batches using significant and equivalency tests
  • Estimation of probability of OOS occurrence using graphical and numerical tests
  • 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
  • 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

Questions? Please contact our specialist team.

info@statsoftpharma.com

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