PS Process Validation - StatSoft

PV 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

Learn more! Watch our webinars for free

Process development, validation, verification. Module 3: Process validation
Design, validation and monitoring of a technological process in questions and answers
Analytical method validation, methods and case studies

Questions? Please contact our specialist team.

info@statsoftpharma.com

Recommendations

Read our recommendations and feedback from our customers

“Sanofi-Aventis Sp. z o.o., Medicine Production and Distribution Facility in Rzeszów, uses specialist STATISTICA Pharmaceutical Suite software (Product quality Review and Process Validation modules) purchased from StatSoft Poland, which not...

(...) StatSoft takes into consideration the growing requirements with regard to quality systems and the need of constant quality improvements, and addresses the needs of its customers by providing a...

“(...) Process Validation automatically analyses production data and generates a ready-to-use report containing, among others, relevant descriptive statistics, control sheets, capacity indicators, variation analysis results and statistical conclusions, while all...

“The Design of Experiments module facilitates the correct planning of experiments, taking account of cost minimisation, at the same time maximising the analytical value of data. The multidimensional exploration techniques...

“(...) the professional approach and high quality of training provided helped us expand our knowledge in the scope of the applications of statistics in clinical trials. An important virtue of...

“Due to the growing need for optimisation of stability evaluation activities, Gedeon Richter Polska Sp. z o.o. Commissioned StatSoft Poland to provide a comprehensive system for collecting, storing and analysing...

“Statistica software was implemented at the Espefa Chemical and Pharmaceutical Worker Cooperative by StatSoft with the following modules: Process Validation and Measurement Method Validation. The cooperative decided to implement the...

“Information about the quality of products manufactured and the production process can be obtained with the use of relevant statistical methods. Statistica software has made quality assessment analyses, validation activities,...

“By using the Pharmaceutical Suite, the time needed to perform statistical analysis of data, prepare the results and issue a report has been reduced to just several minutes. The time...

“The use of the Statistica Process Validation software guarantees a correct preparation of reports with significant time savings. Thanks to a transparent and wide scope of information contained in the...

“Statistica provides significant support in ensuring a high quality of medication, facilitates time savings generates transparent and professional reports, which enable us to quickly evaluate the process and which are...

“Using the Statistica Pharmaceutical Suite facilitates big time savings.”

More