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).