Data processing: measuring – calibrating – or testing – Measurement system in a specific environment – Biological or biochemical
Reexamination Certificate
2005-06-07
2005-06-07
Tsai, Carol S. W. (Department: 2857)
Data processing: measuring, calibrating, or testing
Measurement system in a specific environment
Biological or biochemical
C702S024000, C702S084000, C702S182000, C702S184000
Reexamination Certificate
active
06904370
ABSTRACT:
A system, method, and computer-readable medium for the collecting and storing of environmental data, and generating a user report of the environmental data, the user report providing document compliance with U.S. Food and Drug Administration requirements. The collected and stored environmental data includes a wide variety of manufacturing facility parameter data, including but is not limited to, the presence of viable microbiological organisms, the presence of particulates and other environmental conditions within the facility, such as humidity, pressure, temperature, water quality (e.g., pH, conductivity, total organic content (TOC), endotoxin, coliform, and metals), and the respective amounts of different materials involved in the manufacture of the end product(s).
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Galliani Victoria
Joyce Timothy P.
Levinson George M.
Banner & Witcoff , Ltd.
Compliance Software Solutions Corp.
Tsai Carol S. W.
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