Stability testing, also known as shelf-life assessment, stand as a pivotal stage in the pharmaceutical development, crucial for verifying the identity, potency and purity of ingredients within a formulation. Pharmaceutical stability is defined as the ability of a specific formulation within its designated container to maintain conformity to its physical and chemical protective standards. In […]
Many companies in regulated industries such as pharmaceutical manufacturing or life-sciences are using Statistica successfully in the domains of quality assurance & control and process monitoring. We as StatSoft would in fact claim that these are the areas where Statistica delivers the highest return on investment. Why is that? Statistica offers the analytical functionality that is […]
Alteryx Designer for Pharmaceutical Use Cases Alteryx Designer is a powerful tool suited for many different challenges in the domain of data science. It delivers strong capabilities for data ingestion, preparation (or wrangling), getting insights and distributing (or exporting) them to the right places. All of this is not only available ad-hoc but can also be […]
The implementation of CPV in the pharmaceutical sector has become a necessary requirement within process validation by regulatory authorities (FDA, EMA).
Background and Challenges In a highly regulated industry like pharmaceuticals, companies have to document and manage their production processes and according data continuously, as well as put them to use in order to optimize their own processes and products. This also applies to CSL Behring. The globally active company develops biotherapies from plasma – in […]