Skomputeryzowane systemy zarządzania informacją - StatSoft

Quality

One of the objectives of the Pharmaceutical Quality System according to ICH Q10 is to develop and use effective monitoring and control systems for process performance and product quality to promote continual quality improvement across the entire product lifecycle. Computerised information management systems with statistical data analysis methods can be used to build an integrated approach to acquiring, analyzing, storing, and disseminating information related to products, manufacturing processes and components.

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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...

Senior QA Specialist for Systems

(...) 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...

Quality Director,
Polfa Warszawa S.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...

Validation Specialist
Pol-Nil S.A.

“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...

Pharmaceutical Department, Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz

“(...) 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...

Head of the Clinical Trials Department
Adamed Sp. z o.o., ADAMED Group

“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...

Quality Management Director
Gedeon Richter Polska

“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...

Chief Quality Management System Specialist
ESPEFA

“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,...

President of the Management Board, CEO
Herbapol Wrocław

“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...

Head of the GMP Department,
PPF Hasco-Lek S.A., HASCO Group

“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...

Validation Coordination Specialist,
Jelfa S.A. Valeant Group

“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...

Quality Director
EMO-FARM Sp. z o.o. Valeant Group

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

Chief Validation Specialist
BIOTON S.A

Quality

Recommendations

StatSoft Polska Sp. z o.o.

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