Glossary
21 CFR Part 11 – 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.
Acknowledge
Alarm – A user can acknowledge an alarm to record some corrective action
report against an Active Alarm.
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).
Auto-dialler – 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 of many users.
FCC – Federal Communications Commission.
FDA – Food and Drug Administration. A regulatory body in the
USA.
Firmware – The software program operating the
various components of RF500 e.g. Transmitter, RF module and RF500 Gateway.
Frequency – Number of oscillation cycles-per-second
of a radio signal.
IE – Microsoft Internet Explorer.
IP address – Internet Protocol address. Unique identifier
for each device connected to a network.
ISP – Internet
Service Provider.
Licence free – Term used to describe
the frequency band in which the system operates in terms of licence to broadcast.
RF500 uses the licence free ISM band of 2.4GHz where operators and users are
not required to purchase any kind of licence in order to use the product.
Password – A password is a string of characters that
is used for user authentication. The password is personal and should be kept
secret. Pt100 – Platinum Resistance Device for measuring temperature.
RF – An abbreviation of the words Radio Frequency. Commonly
used to describe “wireless radio communication”.
RH –
Relative Humidity. The amount of water vapour present in the atmosphere expressed
as a percentage of the maximum that could be present at the same temperature.
Users – A user is anyone who is able to log onto an
IT system such as RF500.
Still Need Help? Send Comark an e-mail...
and we'll get back to you.