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Glossary E - F

E
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.
F
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.
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