Comark RF500A - Manual (Page 63)

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Glossary
21 CFR – The FDA (Food and Drug Administration) in the USA, issued regulations Title 21 CFR (Code of Federal
Regulations) Part 11 that provide criteria for acceptance by FDA or an approved regulatory body, for the acceptance
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 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 data logger for instance 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 RF500 system is designed to aid compliance with 21
CFR Part 11.
Administrator – An Administrator is a user who has unrestricted access to all Gateway functions.
Antenna – Electrical device for collecting or disseminating RF energy. The interface between a radio transmitter or
receiver and transmission medium (air).
Autodialler – A device when triggered (by Gateway alarm for example) to dial a specific telephone number to
playback a pre-recorded alarm message.
Ethernet/Network/LAN – Terms used to describe the connection of the Gateway to various users with access to the
system. Personal Computers are connected together using a network via Ethernet ports combining to make a Local
Area Network.
FCC – Federal Communications Commission.
Firmware – The software program operating the various components of RF500 e.g. Transmitter, RF module and
RF500 Gateway.