PS Production Environment Monitoring

The program is used to develop part of the report of the periodic environmental monitoring, related to statistical analysis of data. The module was designed to assess the environmental parameters of sterile and non-sterile manufacture, being subject to periodic analysis of the trends.

Basic module functions:

  • Environmental data analysis using the method of action/alarm limits, contamination recovery rate USP 1116 and analysis of rare events
  • Determination of the limits of action/alarm for data showing normal distribution and non-normal distribution
  • Visualization micro-organisms profile, broken down by type and genius using Pareto graphs/pie chart
  • Evaluation of frequency of OOT/OOL root cause occurrence using Pareto chart
  • 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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