“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 only meets our own expectations, but also the expectations of inspectors from pharmaceutical authorities. The use of STATISTICA software continuously generates time savings based on data analysis and report preparation. (…)
We have also used the software validation service provided by the StatSoft team, who run and documented the process in an efficient and professional manner.

(…) 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 number of solutions for the pharmaceutical sector, which meet legal requirements and allow the user to significantly improve their work and increase efficiency. We were interested in: The Pharmaceutical Suite (Product Quality Review, Stability Assessment, Environmental Monitoring) and the Laboratory Suite (Measurement Method Validation, Measurement Uncertainty Determination, Intra-Laboratory Studies). The software offered by StatSoft meet a wide range of GMP requirements and is validated according to GAMP5. (…)

“(…) 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 calculations can be performed simultaneously for several series. Working with the software is only limited to entering data and selecting relevant analysis options, so it can be used even by less qualified personnel, while specialists can only draw conclusions”.

“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 offered by the Statistica software are an effective tool which supports data analysis and development of new pharmaceutical formulations.

(…) A big advantage of the Measurement Validation Module is the transparent summary of results in the form of a validation report, which makes work at the analytical laboratory much easier”.