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Glossary J - N

J
Japanese Pharmacopoeia (JP) Official Pharmacopoeia of Japan.
JPMA Japan Pharmaceutical Manufacturers Association
JAS-ANZ Joint Accreditation System, Australia & NZ
JetDirect MIO LAN card The network interface card previously used in Hewlett-Packard printers and adopted for use in the 6890 Plus Gas chromatograph.
L
(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
M
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
N
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)