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.
www.gosymbion.com
800.462.9466

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