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The following terms are used in this Reference Manual.
21 CFR -
The regulations issued by the FDA (Food and Drug Administration) in the USA,
under Title 21 of the CFR (Code of Federal Regulations) Part 11 that provides the criteria for
acceptance by the FDA, or an approved regulatory body, of electronic records, electronic
signatures, and handwritten signatures executed to electronic records as equivalent to paper
records and handwritten signatures executed on paper. These regulations, which apply to all
FDA program areas, are intended to permit the widest possible use of electronic technology,
compatible with the FDA’s responsibility to promote and protect public health. Part 11
expressly applies to any record governed by an existing FDA predicate rule that is created,
modified, maintained, archived, retrieved, or transmitted using computers and/or saved on
durable storage media. In other words, any record from a Diligence 600 transmitter, that is at
some stage stored on a PC or where a PC is used to retrieve the data, 21 CFR Part 11 can be
applied. The Diligence 600 WiFi Monitoring System is designed to aid compliance with 21 CFR
Part 11.
AP -
Describes the Access Point or Setup Mode used for setting up Diligence 600
transmitters via WiFi
Buzzer -
Describes the internal sounder for warning of alarm conditions on Diligence 600
transmitters.
Diligence Cloud -
Refers to the Comark application that sits on cloud-based servers on the
internet. The Diligence Cloud is a data storage and management platform for the estate of
WiFi transmitters, which can be connected to via any internet enabled device with a web
browser.
LCD -
Describes the liquid crystal display of the Diligence 600 transmitters that displays
channel and alarm information including readings and warnings.
LED -
Describes the various visual (light emitting diode) indicators on the Diligence 600
transmitters that indicate current status.
Lumberg -
Refers to the Lumberg 6-Pin connection type as used by the Diligence 600
transmitters, probes and accessories. It is designed to provide a robust and rugged means of
connection preventing accidental removal and ingress.
Task -
Describes a set of instructions from the Diligence Cloud that is sent to a transmitter in
order to program it with the instructions to carry out logging and reporting on alarms.
WiFi -
The wireless network to which Diligence 600 transmitters connect in order to send
their measurement data to the Diligence Cloud.