| EBR |
Electronic Batch Record |
| EA |
European co-operation for Accreditation. Merged
in November 1997 from the European Accreditation of Certification
(EAC) and European co-operation for the Accreditation of
Laboratories (EAL). A major role for EA is to develop, evaluate and
ensure the maintenance of conformity assessment bodies. Membership
of EA consist of the nationally recognized accreditation bodies of
the European Union and EFTA. Other non EU/EFTA nations, with
nationally recognized accreditation functions, in line with
international standards, may also join as Associate Members. |
| EAC |
European Accreditation of Certification (EAC).
Merged in 1997 with the EAL into the EA. |
| EAL |
European co-operation for
the Accreditation of Laboratories (EAL). Merged in 1997 with the EAC
into the EA. |
| EAM |
Enterprise asset
management |
| EBR |
Electronic batch record |
| EC |
European Community. See
also European Union. |
| ECA |
Europeam Compliance
Academy (ECA)
The European Compliance Academy (ECA) is an independent educational
organisation chaired by a Scientific Advisory Board with members of
the pharmaceutical industry and regulatory authorities. The concept
of each conference and Education Course has to be approved by this
committee. The objective of ECA is to bring together European
Industry and regulatory representatives in order to discuss new
development in QA and GMP compliance within the pharmaceutical
industry. The main focus is to support a European view which means
that, as the result of the new European market, GMP compliance
issues will become more focused on the regulatory demands of the
European Community. Other standards, e.g. those of the FDA, will
also be discussed. |
| ECP |
Early compound profiling |
| ECPHIN |
European Community
Pharmaceutical Information Network |
| eCTD |
electronic Common
Technical Document |
| EDMF |
European Drug Master File |
| EDMS |
Electronic Document
Management System.
EDMS controls and retains documents from creation to archiving and
all stages in between. |
| EDQM |
European Department for
the Quality of Medicines
The European Directorate for the Quality of Medicines evolved from
the technical secretariat of the European Pharmacopoeia; this
evolution was necessary because new responsibilities and activities
had developed.The success of the biological standardisation
programme for medicines for human use, run by the European
Pharmacopoeia Secretariat, led to initiating further collaboration
between the Commission of the European Communities and the Council
of Europe in the area of the quality control of medicines. |
| EEC |
European Economic
Community |
| EFPIA |
European Federation of
Pharmaceutical Industry Association |
| EFTA |
European Free Trade
Association |
| EIR |
Establishment Inspection
Report . Written after an FDA inspection by the agency. The
observations from 483's are classified as no action indicated (NAI),
voluntary action indicated (VAI) of official action indicated (OAI). |
| Electronic
Orange Book |
List of Approved Drugs |
| Electronic record |
Electronic record means any combination of text, graphics, data,
audio, pictorial, or other information representation in digital
form that is created, modified, maintained, archived, retrieved, or
distributed by a computer system.
Examples for analytical laboratories are
- methods for instrument control and data evaluation
- calibration tables
- original data as captured by the computer
- processed data
- analysis reports
- chromatograms with baselines
- log books
- audit trails.
|
| Electronic signature |
Electronic signature means a computer data
compilation of any symbol or series of symbols executed, adopted, or
authorized by an individual to be the legally binding equivalent of
the individual's handwritten signature. |
| EMAS |
Eco Management and Audit Scheme |
| EMEA |
European Agency for the Evaluation of Medicinal
Products |
| Embedded Software or
Firmware |
Embedded means that the program can not be
changed by the user. The program is only be changed if it is
accompanied by a physical hardware change. The typical embedded
program is supplied in the for of e ROM chip (e.g., EPRPOM) placed
or embedded in the equipment hardware. |
| EMI |
Electromagnetic Interference - Any
electromagnetic radiation released by an electronic device that
disrupts the operation or performance of another device.
EMI is produced by many sources commonly found in an office
environment, including fluorescent lights, photocopiers, and motors
such as those used in elevators. EMI is also produced by natural
atmospheric or solar activity
(Ref: Dyson, Dictionary of Networking) |
| EMS |
Environmental Monitoring System |
| EN 45001 |
"General criteria for the operation of testing
laboratories." A European standard specifically intended for
operating testing and calibration laboratories. EN 45001 is
typically used as a guide against which a laboratory’s quality
system can be evaluated for accreditation. Most probably replaced by
ISO17025. |
| EOQ |
European Organization for Quality |
| EPA |
Environmental Protection Agency of the United
States Government. A regulatory body who develops and enforces all
aspects of environmental monitoring. This includes development of
analytical methods. |
| Equipment |
Defined as the analytical measurement hardware
including the firmware, for example, a gas chromatograph. In a
computerized system the equipment is controlled by the computer
system. The computer system collects measurement data from the
equipment. |
| eRAC |
Electronic Records Advisory Committee |
| ERP |
Enterprise Resource Planning |
| Error |
The difference between an individual result and
the true value of the quantity being measured |
| ERS |
Electronic Record System |
| Escrow |
Ancient legal term also applied to the deposit
of source code by the software developer with an independent third
party called the Escrow agent. The agent holds the source code upon
the terms and conditions set out in the Escrow agreement which
allows him to release it to specified users of the software in
certain circumstances. These circumstances are usually the
bankruptcy, or liquidation of the software developer, or the failure
by the developer to carry out any maintenance obligation under the
license agreement. |
| ESRA |
European Society of Regulatory Affairs |
| Ethernet |
A popular network protocol and cabling scheme
with a transfer rate of 10Mbps, originally developed at Xerox in
1970 by Dr. Robert Metcalf. Ethernet uses a bus topology, and
network nodes are connected by either thick or thin coaxial cable,
fiber-optic cable, or twisted-pair cable.
(Ref: Dyson, Dictionary of Networking) |
| EtherTwist cable (pix) |
The standard 100 BaseT LAN twisted pair cable
used to connect instruments to a hub and to the corporate LAN
(Agilent part number G1530-61485). |
| EU |
European Pharmacopeia |
| Eucomed |
- European Confederation of Medical Devices Associations
- Membership is composed of companies and national and
European associations
- Provide links to other international regulatory sites
- Produces a weekly Journal
- Focus Groups
|
| EUDAMED |
European Database on Medical Devices |
| EudraNet |
European Union Drug Regulatory Agencies |
| EURACHEM |
Established in 1989, provides a focus for
analytical chemistry and quality related issues in Europe. Develops
useful guidance documents for analytical chemists in the area of
method validation, measurement uncertainty etc. |
| EuroALMA |
European Analytical Laboratory Manager's
Association
An organization in Europe. |
European Analytical
Laboratory Manager's Association
An organization in Europe. |
Formed in 1990 through a Memorandum of
Understanding (MOU) between the EC/EFTA members and CEN/CENELEC.
Their goal is to harmonize Certification and Accreditation in
Western Europe (EC and EFTA) in non regulated product areas for
mutual recognition of standards and accreditation throughout the EC
and EFTA countries. |
| European Pharmacopoeia |
Official compendium of the member states of the
Council of Europe, which includes all EC and EFTA countries. |
| European Pharmacopoeia
Commission |
Publishes the European Pharmacopeia (EP), the
official compendium recognized by members of the European Union. |
| European Union (EU) |
Members in 1995 are Austria, Belgium, Denmark,
Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the
Netherlands, Portugal, Spain, Sweden and the United Kingdom.
Formerly called European Community (EC) and European Economic
Community (EEC). |
| External audit |
Also known as third party audit. A periodic
process carried out by an external body, e.g., National Measurement
Accreditation Service (NAMAS), to check that the laboratory’s
quality assurance system is effective, documented and adhered to by
all staff |
| External reference
specifications (ERS) |
A Hewlett-Packard document that lists the
requirements a new product under development is expected to fulfill. |
| FAT |
Factory acceptance testing
This is conducted by the purchaser of equipment at the site of the
manufacturer of the equipment prior to being shipped. This is to
ensure that the equipment meets predetermined specifications. For
more details, check
http://www.smbvalidation.com/qfat.html |
| FDA |
Food and Drug Administration, U.S. agency, part
of the Department of Health and Human Services, responsible for
regulating clinical research and approval of marketing permits for
food, drugs, medical devices and cosmetics in the U.S. |
| FDAMA |
FDA Modernization Act |
| FDC |
Food Drug and Cosmetics Act |
| FDA compliance policy
guide |
FDA manual for FDA field operations personnel
that contains policy guidance on FDA interpretations of regulations
and other compliance policies. |
| FDA guidance documents |
Document published by U.S. Food and Drug
Administration to provide drug sponsors with informal guidance on
specific FDA requirements. Unlike regulations, guidelines are not
legally binding. Alternative approaches can be used to implement
specific requirements. |
| FDA Inspectors Technical
Guide |
Guide published by the Food Drug Administration
to its field inspectors. It is intended as a vehicle for making all
FDA inspectors aware of selected technical information not
previously available on a broad scale. Some of the topics addressed
are lyophilization of parenterals, measurement of relative humidity
in the ETO process, evaluation of production cleaning processes for
electronic medical devices, bacterial endotoxins, ration dating for
drugs, new equipment static mixers, diathermy, and ethylene oxide
sterilization. |
| FDA recommendations |
A means the U.S. Food and Drug Administration
uses to disseminate information about matters authorized by, but not
involving direct regulatory action under the laws the agency
administers. Recommendations are not legally binding on
manufacturer. |
| FD&C |
Federal Food, Drug, and Cosmetic Act |
| FDS |
Functional design specification |
| FI |
Failure Investigation |
| FIP |
International Pharmaceutical Federation |
| FIR |
Failure Investigation Report |
| FIRA |
Federal Insecticide, Fungicide and Rodenticide
Act |
| Fiber-optic cable |
A transmission technology that sends pulses of
light along specially manufactured optical fibers.
Each fiber consists of a core, thinner than a human hair, surrounded
by a sheath with a much lower refractive index. Light signals
introduced at one end of the cable are conducted along the cable as
the signals are reflected from the sheath.
Fiber-optic cable is lighter and smaller than traditional copper
cable, is immune to electrical interference, offers better security,
and has better signal-transmitting qualities. However, it is more
expensive than traditional cables and is more difficult to repair.
Fiber-optic cable is often used for high-speed backbones, but as
prices drop, we may even see fiber-optic cable running to the
desktop.
(Ref: Dyson, Dictionary of Networking) |
| File server |
A networked computer used to store files for
access by other client computers on the network.
On larger networks, the file server runs a special network operating
system. On smaller installations, the file server may run a PC
operating system supplemented by peer-to-peer networking software.
(Ref: Dyson, Dictionary of Networking) |
| FIP |
International Pharmaceutical Federation |
| Firmware |
The combination of a hardware device, e.g., an
Integrated Circuit, and computer instructions and data that reside
as read only software on that device. Such software can not be
modified by the computer during processing. |
| Firewall |
Device that controls data traffic between
networks by providing a barrier between them. Most commonly
organizations deploy firewalls between themselves and the Internet.
A Firewall is usually a standalone device that provides only
firewall protection. Most firewalls have a minimum of two network
cards - one connected to the trusted network and the other to the
untrusted network. (Ref.: Reeves, Network+) |
| FMEA |
Failure Mode and Effect Analysis |
| FOI |
Freedom of Information |
| Food and Drug Law
Institute |
- FDLI provides a neutral forum for the examination of FDA
regulations (publications, conferences, workshops, and new
videoconferences, also offers these over the Internet) Web site
includes:
- Audiotapes and videotapes from past conferences
- Academic information for professors, schools, and students
- Updated newsletter - available on-line (free to members)
- New publication - Application of Pharm. CGMPs
- Food and Drug Law Journal - (abstracts and table of
contents), (search by subject)
- Lawyers and consultants directory on-line
- New CD-Roms
|
| Forward Lookup |
Converts an Internet name to an address.
Reverse IP address lookup converts the number to the name. |
| FS |
Functional Specification |
| FTA |
Fault Tree Analysis |
| FTP |
File Transfer Protocol - The TCP/IP Internet
protocol used when transferring single or multiple files from one
computer system to another.
FTP uses a client/server model, in which a small client program runs
on your computer and accesses a larger FTP server running on an
Internet host. FTP provides all the tools needed to look at
directories and files, change to other directories, and transfer
text and binary files from one system to another.
(Ref: Dyson, Dictionary of Networking) |
| Functional specification |
A written definition of the function that a
system or system component can perform |
| Functional testing |
Also known as black box testing because source
code is not needed. Involves inputting normal and abnormal test
cases, then evaluating outputs against those expected. Can apply to
computer software or total system. |