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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.


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