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Secure, Streamlined PAT Deployment

The vendor’s Appliance is a hardware device that is said to provide the first fully locked-down approach to the deployment of analytical instruments in a process environment.

The deployment of analytical systems under the governance of FDA regulations is an ongoing concern for scientists and engineers wishing to transfer their research and development efforts to the process environment. The Appliance addresses this concern by providing a limited set of locked-down and rigorously tested algorithms—thus inherently providing for the compliance under 21 CFR Part 11. Each algorithm is dedicated to a specific method and application, controlling a specified analytical instrument and sampling system, accepting structured inputs from the instrument, and providing outputs in the form of process variable predictions. The hardware is a ruggedized, yet standard off-the-shelf single-board industrial device. It contains a solid-state hard drive and is ready for immediate deployment in a process environment. The interaction with the appliance is via a choice of a thin client or a client/server—allowing the user, with appropriate permissions, to select from the dedicated set of algorithms, each of which is designed for a specific Process Analytical Technology (PAT)-related application such as drying, blending or reaction monitoring.

Symbion Systems Inc.

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