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 required in these fields. Loading data, preparing it, and analyzing it with the required and other methods and to document the results properly is fully supported by Statistica. All of that can be automated and manual modifications can be reduced to a minimum.
- Statistica offers a platform that satisfies the requirements (stemming from regulation) regarding correctness, preventing manipulation and avoiding process interruptions (e.g. 21 CFR Part 11) and processes can be designed in a way that they can pass a validation.
How does Statistica satisfy the requirements that are given in (for example) pharmaceutical production?
Complete analyses and analytical building blocks, data sources and models are managed by Statistica Server in a centralized repository. Server has the following features:
- Access restrictions with user rights and groups
- Approval mechanisms ensure that changes can only be made with a four-eyes principle.
- Versioning of all elements to let previous versions stay available. This way system modifications can also be documented.
- Audit Trails can be used to track changes.
- The system can be deployed on multiple stages (e.g. DTAP or Development + Production).
- Various ways to execute processes: Manually, scheduled or via WebService.
- All elements can be documented to make teamwork easier.
In addition, Statistica offers features that are very valuable in these industries:
- A system for manual data entry (for example in the lab). With it you can digitize data entry, and avoid mistakes with various mechanisms like type checks, double blind entry, and four-eyes principle.
- Statistica is a low code / no code environment that enables users to set up analyses without any programming skills. This accelerates onboarding of new team members and can reduce the validation efforts drastically.
- Statistica supports all analytical methods that experts require: Regression analysis, comparison of means, non-parametrical tests, statistical process control, capability analysis, quality control charts, design of experiments, and many more.
- Proper documentation of the algorithm ensures that the calculations lead to the expected results. Statistica can be numerically validated.
There is much more in Statistica to ensure that customers can make their production more robust and gain insights.
Don’t hesitate to get in touch!
Learn more about Statistica here
