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).