StatSoft, makers of the STATISTICA software platform and one of the largest producers of enterprise manufacturing intelligence, multivariate statistical process control, and predictive analytics software solutions, released an updated and expanded Pharmaceutical and BioPharmaceutical industry solutions section to its web site. The solutions section includes overviews of StatSoft’s software solutions for Pharmaceutical and BioPharmaceutical research & development and manufacturing, presentations by StatSoft’s customers, and case studies.
One of StatSoft’s case studies describes the benefits of the use of the STATISTICA Enterprise manufacturing intelligence server platform for multivariate statistical process control, automated trending, and compliance reporting by a contract manufacturers of biologics. This contract manufacturer achieved its initial return on investment from STATISTICA through the reduction of scrapped batches through online process monitoring. The STATISTICA solution for this contract manufacturer is utilized at multiple sites worldwide as the validated, GMP (Good Manufacturing Practices) analytics system, integrated with the company’s LIMS (Laboratory Information Management System) and data historian (the PI ™System from OSISoft).
The continuing adoption of Process Analytical Technology (PAT) and Quality by Design (QbD) is an important development in the application of analytics for manufacturing intelligence, providing the framework and justification for company’s integration of analytics in data collection, data management and aggregation, process understanding, technology transfer, process monitoring, and compliance reporting. “We are excited about the expansion of our successes in the Pharmaceutical and BioPharmaceutical industries as a result of QbD and PAT initiatives,” said Robert Eames, VP of Solutions for Life Sciences North America, “and the updated solutions section on StatSoft.com highlights the opportunities for companies to deploy STAT
ISTICA, a configurable, commercial off the shelf, validated analytics platform for automated process monitoring, multivariate statistical process control, compliance reporting, batch genealogy, transition analysis, product stability and shelf life monitoring, and other critical applications for process understanding and control.”