“(…) 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 StatSoft are punctuality and involvement in the project, as well as excellent contact between the lecturer and the participants during the course.”
“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 stability-related data. (…)
By implementing the comprehensive data gathering and analysis system:
Storage of hard-copies of data has been reduced – all data are now stored in one structured analytical database,
Data security has been increased with the use of the right IT infrastructure, privilege management and change tracking function,
Fast access to data has been achieved – necessary information, e.g. results of the analysis of a selected parameter in a selected period and stability test plans for the next month can be obtained by generating a special report,
It has become possible to quickly generate reports etc. with all results for a selected series or a summary report with test results for a selected product,
The Stability Assessment solution from the Pharmaceutical Suite has become available, which automates data analysis and final report generation.
Currently our work in the scope of data processing is only limited to entering data through a dedicated interface, and afterwards the person responsible for the analysis or report defines the scope of data required, which are transferred into the analytical environment, where they can be viewed and processed or automatically analysed and included in a report – which significantly reduces the time needed to prepare documentation. In addition, we have gained an analytical database, which stores all historical information regarding parameters and products.
A reliable approach to the user’s expectations, professionalism and experience of the StatSoft team enabled them to efficiently adjust the software to the requirements of Gedeon Richter Polska. The professionalism and flexibility of StatSoft have accelerated and simplified a successful deployment of the new solution.”
“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 solution to meet the requirements of GMP in the scope of production process validation, test method validation and preparation of trend analysis and annual product review reports. (…)
With the StatSoft software, working with data processing and statistical calculations has become much easier, less time-consuming and the risk of errors while copying data has been eliminated, as the software is validated during its deployment by a representative of StatSoft, which is also very important with regard to Good Manufacturing Practices.
Reports generated by the Process Validation and Measurement Method Validation modules contain all necessary statistical analyses and conclusions, and if needed, the user can include additional information in the reports. (…)
While deploying the software, StatSoft provides exhaustive training and offers assistance, which makes working with the software and understanding complex issues related to statistical analysis becomes easier and very useful in everyday work.
“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, stability evaluation and calculations which support technological processes much more efficient.
The software is user-friendly and simple to use. It allows us to perform complex statistical analyses with the use of build-in functions and templates, which significantly reduces the evaluation time.
Thanks to the training provided by an expert from StatSoft in the form of workshops, the software has been implemented correctly and is used effectively by our company”.