| (Laboratory)
accreditation |
Formal recognition that a testing laboratory is
competent to carry out specific tests or types of tests (EN 45001) |
| LabCompliance |
The Ultimate resource for national and international compliance
issues in analytical laboratories.
- Basics and detailed references for validation/qualification
of equipment - computers - methods - data - reference materials
- people.
- Links to regulations such as GLP, GMP, 21 CFR Part 11and
quality/accreditation standards such as ISO Guide 25, EN45001
etc.
- News section with frequent updates on latest information
- Purchase online or download selected documents at no charge
(download for users club members only)
- Provides links to regulatory agencies all over the world -
America, Europe, Africa, Asia and Australia
- Provides links to international and national standards and
accreditation bodies
- Provides links to national and international
validation/compliance conferences
- Links to companies providing validation and compliance
services all over the world - America, Europe, Asia and
Australia
- Search engine and extensive glossary with internet links to
public and private organizations
- On-line shopping of validation reference books
- Will have Internet discussion forums (not yet available)
|
| LAGER |
Legal Acceptability Guide for Electronic
Records |
| LAN |
Local-area network - A group of computers and
associated peripheral devices connected by a communications channel,
capable of sharing files and other resources among several users
(Ref: Dyson, Dictionary of Networking). A LAN provides a means of
communications between network nodes. A LAN provides a means of
communications between network nodes. |
| LAN switch |
Furnishes the actual path in and out of a
gateway for a given data packet. |
| LIMS |
Laboratory Information Management System. |
| Live tests |
Live, user-site tests: these tests are
performed in the end user's computing environment under actual
operating conditions. Testing should cover continuous operations for
a sufficient time to allow the system to encounter a wide spectrum
of conditions and events in an effort to detect any latent faults
that are not apparent during normal activities (Part 11 validation
guidance, draft version) |
| LOD |
Limit of detection. The lowest concentration of
an analyte that the analytical procedure can reliably differentiate
from the background noise. |
| LOQ |
Limit of quantification. The amount of an
analyte in a sample that can be determined with previously specified
precision. |
| LRQA |
Lloyd's Register Quality Assurance (LRQA)
offers quality environmental and health &
safety management system certification and training services |
| MAA |
Application to a Marketing Authorization |
| MAC address |
A Media Access Control (MAC) address is a
unique 12-digit Hex address given to every piece of hard-ware
connected to an Ethernet network. No two addresses are the same. |
| Macro |
Mini program that performs a specific task - to
repeat steps perfectly and with much greater speed. In Excel Macros
are written in a programming language called Visual Basic for
Applications (VBA). In Excel Macros don't have to be created, they
are recorded as keystrokes and mouse actions |
| MARSQUA |
Mid-Atlantic Region Society of Quality
Assurance |
| MCA |
Medicines Control Agency |
| MDA |
Medical Device Agency |
| (MDMA) |
Medical Device Manufacturers Association |
| MDR |
Medical Device Reporting (MDR) regulation
became final on December 13, 1984. As a result of changes mandated
by the Safe Medical Devices Act (SMDA) of 1990, and the Medical
Device Amendments of 1992, the 1984 MDR regulations (21 CFR 803 &
807) were revised and published on 12/11/95. The FDA Modernization
Act of 1997 made additional changes to MDR and a revised MDR
Regulation was proposed in May 1998. The final MDR regulation was
published in the Federal Register on January 26, 2000. |
| MedDRA |
Medical Dictionary for Drug Regulatory Affairs |
| Media |
This is what carries the signal on the network.
Media can be various things, such as copper, glass, or air. |
| Medical Device
Manufacturers Association (MDMA) |
- Links provided are broken down by 3 categories
1.Industry Organizations
2.Industry Resources
3.Government
Monthly newsletter "Critical Issues" can be downloaded
Membership information
|
| MES |
Manufacturing Executing System |
| Meta data |
Data about data. In chromatography data that
are important to reconstruct a final report from raw data. In
chromatography these are integration parameters and calibration
tables. |
| MHRA |
Medicines and Healthcare Products Regulatory
Agency UK, formerly Medical Control Agency,MCA |
| MMI |
Man machine interface (screen specifications,
data entry modes) |
| MMS |
Maintenance management system |
| Modem |
Contraction of modulator/demodulator; a device
that allows a computer to transmit information over a telephone
line.
The modem translates between the digital signals that the computer
uses and analog signals suitable for transmission over telephone
lines. When transmitting, the modem modulates the digital data onto
a carrier signal on the telephone line. When receiving, the modem
performs the reverse process to demodulate the data from the carrier
signal.
Modems usually operate at speeds up to 56Kbps over standard
telephone lines and at higher rates over leased lines.
(Ref: Dyson, Dictionary of Networking) |
| Modem server |
A LAN server that allows a network user to dial
out of the network into the Public Switched Telephone System or to
access leased lines for asynchronous communications. Also called an
asynchronous communications server or a dial-in/dial-out server.
(Ref: Dyson, Dictionary of Networking) |
| MOH |
Ministry of Health, the most commonplace
designation for a country’s Health Regulation Authority. |
| MOU |
Memorandum of Understandin |
| MQD |
Measurement Quality Division |
| MRA |
Mutual Recognition Agreement |
| MRFG |
Mutual Recognition Facilitation Group |
| MRP |
Mutual Recognition Procedure |
| MRP |
Material Requirements Planning System |
| MRPII |
Manufacturing Resource Planning System |
| NACLA |
National Cooperation for Laboratory
Accreditation |
| NADA |
New Animal Drug Application |
| NAFTA |
North American Free Trade Agreement |
| NAI |
No Action Indicated. Observation category in
FDA's establishment inspection reports |
| NAMAS |
National Measurement Accreditation Service in
the United Kingdom. |
| NARA |
National Archives and Records Administration
(in the United States) |
| National standard |
A standard that is adopted by a national
standards body and made available to the public. |
| NCE |
New Chemical Entity |
| NCP |
Network Control Program - In an IBM Systems
Network Architecture (SNA) environment, performs the routing, error
control, testing, and addressing of SNA devices.
(Ref: Dyson, Dictionary of Networking) |
| NCSL |
US National Conference of Standards
Laboratories |
| NDA |
New Drug Application. New drug application. A
New Drug Application is an application requesting FDA approval to
market interstate commerce a new drug for human use. The application
must contain among other things, data from clinical studies needed
for FDA review from specific technical viewpoints, including
chemistry, pharmacology, biopharmaceutics, statistics, and anti-infectives,
microbiology. Detailed instructions for the submission of NDA's can
be found in 21 CFR 314. |
| NELAC |
National Environmental Laboratory Accreditation
Conference |
| Network Interface Card
(NIC) |
Network Interface Card - In networking, the PC
expansion board that plugs into a personal computer or server and
works with the network operating system and the appropriate device
drivers to control the flow of information over the network.
The network interface card is connected to the network media
(twisted pair, coaxial, or fiber-optic cable) and is designed for a
specific type of network such as Ethernet, token ring, FDDI (Fiber
Distributed Data Interface), or ARCnet.
Novell NetWare documentation uses the term network board rather than
the more common term network interface card.(Ref: Dyson, Dictionary
of Networking)
A basic network interface card consists of network connector, a set
up disc, a diagnostic disc, and a set of operating system driver
discs. |
| New Drug Application |
See NDA |
| Newsgroups |
Discussion groups, for example, on the
Internet, that anyone can join, reading and posting articles in a
worldwide forum. In 1997 there were about 10,000 discussion groups
on the Internet discussing almost any imaginable topic. |
| Network |
A group of computers and associated peripheral
devices connected by a communications channel capable of sharing
files and other resources among several users.
A network can range from a peer-to-peer network connecting a small
number of users in an office or department, to a LAN connecting many
users over permanently installed cables and dial-up lines, to a MAN
or WAN connecting users on several networks spread over a wide
geographic area.
(Ref: Dyson, Dictionary of Networking) |
| Network architecture |
The design of a network, including the
hardware, software, access methods, and the protocols in use.
Several well-accepted network architectures have been defined by
standards committees and major vendors. For example, the
International Organization for Standardization (ISO) developed the
seven-layer OSI Reference Model for computer-to-computer
communications, and IBM designed SNA (Systems Network Architecture).
Both architectures organize network functions into layers of
hardware and software, with each layer building on the functions
provided by the previous layer.
The ultimate goal is to allow different computers to exchange
information freely in as transparent a fashion as possible.
(Ref: Dyson, Dictionary of Networking) |
| Network device driver |
Software that controls the physical function of
a network interface card, coordinating between the card and the
other workstation hardware and software.
(Ref: Dyson, Dictionary of Networking) |
| Network drive |
A drive located on a computer other than the
one currently being used and that is available to users on the
network.
(Ref: Dyson, Dictionary of Networking) |
NHPRC
|
National Historical Publications & Records
Commission |
| NIC |
Network Interface Card - In networking, the PC
expansion board that plugs into a personal computer or server and
works with the network operating system and the appropriate device
drivers to control the flow of information over the network.
The network interface card is connected to the network media
(twisted pair, coaxial, or fiber-optic cable) and is designed for a
specific type of network such as Ethernet, token ring, FDDI (Fiber
Distributed Data Interface), or ARCnet.
Novell NetWare documentation uses the term network board rather than
the more common term network interface card.
(Ref: Dyson, Dictionary of Networking) |
| NICPBP |
National Institute of Control of Pharmaceutical
& Biological Products (China) |
| NIH |
National Institutes of Health (USA) |
| NIST |
National Institute for Standards and Technology
in the United States. Formerly called the National Bureau of
Standards Technology (NBS). Responsible for establishing a
measurement foundation to facilitate both national and international
commerce. |
| Node |
Any device attached to the network capable of
communicating with other network devices. In Novell NetWare
documentation, a workstation is often called a node.
(Ref: Dyson, Dictionary of Networking) |
| Node number |
The number that uniquely identifies a network
interface card and distinguishes it from all others.
Node numbers can be assigned in different ways. Ethernet node
numbers are factory-set, so no two Ethernet boards have the same
number. On other network interface cards, node numbers are set by
jumpers or switches.
(Ref: Dyson, Dictionary of Networking) |
| NOEL |
No Observable Effect
Level (for drugs) |
| NORAMET |
North American Cooperation in Metrology.
NORAMET is a regional cooperation in metrology, involving the
national measurement laboratories of Canada, Mexico and the United
States of America. Most of its current activities are focused on
establishing and documenting the degree of equivalence of the
calibration services offered by members. This will be done by
comparisons of key standards and techniques and by exchanges of
visits to establish mutual confidence. The purpose is to facilitate
international trade by providing assurance that each country's
measurement system is traceable to the SI units with stated
uncertainties |
| Nordtest |
Organisation for Testing in the Nordic
Countries |
| NOS |
Network Operating System - In typical
client/server architecture LANs, the NOS consists of two parts. The
largest and most complex part is the system software running on the
file server. This system software coordinates many functions,
including user accounts and network access information, security,
resource sharing, administration, UPS and power monitoring, data
protection, and error detection and control. A much smaller
component of the NOS runs on each of the networked PCs or
workstations attached to the network.
Network operating systems are available from Banyan (VINES), IBM
(OS/2 Warp Server), Microsoft (Windows NT Server and Windows 2000),
Novell (IntraNetWare and NetWare), and Sun Microsystems (Solaris),
and, of course, many versions of Unix are available.
In peer-to-peer networks, a part of the NOS is installed on each PC
or workstation attached to the network and runs on top of the PC
operating system. In some cases, the NOS may be installed on one PC
designated as a file server, but this PC is not dedicated to the
file-server function; it is also available to run applications.
(Ref: Dyson, Dictionary of Networking) |
| NSCL |
National Conference of Standards Laboratories |
| NSCS |
New Swiss Chemical Society |
| NTIS |
National Technical Information Service. Part of
the U.S. Department of Commerce with responsibility for publishing
and sales of technical documents. It has similar publishing
functions as the U.S. Government Printing Office. |
| null modem |
A short serial cable that connects two personal
computers so that they can communicate without the use of modems.
The cable connects the two computers' serial ports, and certain
lines in the cable are crossed over so that the wires used for
sending by one computer are used for receiving data by the other
computer.
(Ref: Dyson, Dictionary of Networking) |
| NVLAP |
National Voluntary Laboratory accreditation
Program. A federal program, under which NVLAP operates as an
unbiased third party to accredit both calibration and testing
laboratories
(http://ts.nist.gov/nvlap) |
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