StatSoft Poland is a distributor of Statistica software in Poland and a partner in the provision of technical support to Polish users of Statistica. Since January 2019, Statsoft Polska is part of the corporate group of arondIT GmbH. For over 20 years, we have been working within the Statistica structures (formerly StatSoft Inc.), specialising in data analysis.
Many years of experience of working with companies from the pharmaceutical and cosmetics sector have enabled us to solve different issues related to data analysis, reporting as well as statistical control and monitoring of production processes (SPC), to provide comprehensive solutions.
We deliver tried and tested solutions for the key areas of pharmaceutical and cosmetic product manufacture. With regard to quality, we provide solutions for:
- product stability trending,
- production environment monitoring,
- process validation and ongoing verification,
- product quality reviews (PQR),
- dissolution profile comparison,
- validation of analytical methods
- as well as estimation of measurement uncertainty.
In the area of production, we offer:
- statistical process control (SPC)
- and overall equipment effectiveness monitoring (OEE),
- we also provide assistance in the scope of measurement system analysis (MSA)
- and preventive/predictive maintenance (PM).
Whereas with regard to technological resources, we offer:
process optimisation based on design of experiments (DOE) and historical data (Data Mining, CART, CHAID).
We do not only offer single tools for data analysis automation and reporting, but also provide integrated systems which facilitate gathering and analysis of data according to the recommendations of the FDA, EMEA and national regulatory bodies with regard to Good Manufacturing Practices (GMP) and Pharmaceutical Quality Systems.
Apart from high-quality analytical and reporting software, whose quality is evidences by the success of our customers, we also provide deployment, validation, consulting and training services. For years we have been the largest organiser of courses and training dedicated to broadly understood statistics and data analysis in Poland. With the pharmaceutical sector in mind, we have created a series of training sessions entitled “Statistics in Pharma”, which, in a user-friendly manner, presents structured in-depth knowledge of the current GMP standards and their practical implications.