Strict standards and guidelines apply in the pharmaceutical industry. Regulatory authorities, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), provide detailed procedures and documentation. Using Statistica and the know-how of StatSoft, we support you in setting up solutions for efficient data analysis in validated system environments.
Generating Annual Product Reviews (APR in the USA) or Product Quality Reviews (PQR in Europe) is a very time-consuming and cost-intensive process. Using Statistica, you can automate the APR and PQR creation process to the greatest possible extent.
Companies in the pharmaceutical industry use statistical methods to calculate the runtime of a product or the repeat testing period of an active ingredient during long-term storage. This is because there are strict requirements from the European approval authorities. The Statistica add-in Shelf-Life Estimation enables you to perform automated calculations according to Q1E specifications.
In order to consistently monitor processes and gain an improved understanding of them, you can use Statistica in an optimal way. Statistica naturally complies with the strict GxP standards.
All solutions enable the standardization of statistical data analysis and analysis as well as the automatic generation of reports in the form of tables and / or graphics and thus contribute to process optimization.
Our applications include the trend towards product stability, monitoring of the production environment, process validation and ongoing review, regular product reviews, solution profiling, and assessment and validation of uncertainties of analytical methods.