OSIsoft RtPM Supports FDA Guidelines on PAT Framework

Real-time Operational Performance Metrics Streamline Validation in the Pharmaceutical Manufacturing Process

SAN LEANDRO, Calif., (March 14, 2005)
OSIsoft, LLC, the global leader in delivering performance management software to the world's leading process manufacturing and life sciences companies, today announced its Real-time Performance Management (RtPM) Platform will support the Food and Drug Administration's (FDA) Process Analytical Technology (PAT) Framework. Building on the flexibility of RtPM, OSIsoft is committed to helping companies meet the goal of the FDA's PAT initiative in pharmaceutical manufacturing.

The goal of the PAT Framework is to provide a deeper understanding of the production process and what critical control parameters and measures impact product quality. Adherence to PAT guidelines will ensure sources of variability are identified and explained, that variability is managed by the process, and that quality attributes are accurately and reliably predicted. PAT will also promote and facilitate real-time product release as opposed to parametric or traditional batch review method of release.

"PAT isn't a single product or technology," explains Alison Smith, senior research analyst, AMR, from a report titled 'PAT Landscape Still a Work In Progress in Life Sciences,' March 2005. "Instead, it's an architecture that incorporates elements of sophisticated instrumentation, real-time data acquisition and storage, analytics, and at its most sophisticated, advanced simulation and control. This will all tie into the reporting frameworks and processes required to satisfy regulatory requirements."

OSIsoft's RtPM, which is powered by the PI System, provides a unique, integrated approach to PAT by aggregating the data in real-time needed to perform multi-variate analysis. RtPM also provides a process data warehouse for storing process control and analyzer data. Using this data, product quality attributes can be accurately and reliably predicted. In addition, the availability of business intelligence metrics within the framework will enable continuous analysis and improvement.

As more accurate data about the production process is gathered, RtPM allows pharmaceutical manufacturers to improve their validation processes in a more streamlined, systematic and measurable manner. This yields a better understanding of the process and enables comprehensive monitoring, as opposed to the current standard of processing and then lab testing the endpoint to ensure accuracy. For multiple facilities which produce the same compound under different conditions or equipment configurations, this saves multiple steps and ultimately, cost and time-to-market.

"Although the process of moving to the PAT framework is voluntary, OSIsoft strongly supports the framework as an industry best practice goal and is working with several of the world's leading pharmaceutical manufacturers and organizations to help realize the potential of this initiative," said Marc Gallant, pharmaceutical industry manager, OSIsoft. "We believe the RtPM Platform is uniquely suited to meet the goals of PAT in real-time release and process optimization and are actively engaging resources to help make this a reality for our customers."

About OSIsoft
OSIsoft (www.osisoft.com) delivers the PI System, the industry standard in enterprise infrastructure, for management of real-time data and events. With installations in 107 countries spanning the globe, the OSIsoft PI System is used in manufacturing, energy, utilities, life sciences, data centers, facilities, and the process industries. This global installed base relies upon the OSIsoft PI System to safeguard data and deliver enterprise-wide visibility into operational, manufacturing and business data. The PI System enables users to manage assets, mitigate risks, comply with regulations, improve processes, drive innovation, make business decisions in real time, and to identify competitive business and market opportunities.

Founded in 1980, OSIsoft, LLC is headquartered in San Leandro, CA, with operations worldwide and is privately held. Learn more about OSIsoft and the PI System at www.osisoft.com.