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Glossary A-B

A
A2LA American Association for Laboratory Accreditation. A non-profit, non-governmental, public service, membership society dedicated to the formal recognition of competent laboratories and related activities. Accredits laboratory for compliance with A2LA’a accreditation standards, that includes ISO17025
AAMI

Association of Advanced Medical Instrumentation

Offers through it's website

  • Topic specific news section
  • Listing of meetings and events
  • Searchable database of available standards, recommended practices and technical information reports (TIRs)
  • Information on ICC (International Certification Commission) certification programs
  • Course and information on complying with the FDAs QS Reg program.
  • Standards book sets
  • GMP / Quality systemsCourses
  • Publications
  • FDA documents
  • Standard monitor on-line
  • a condensed review of recent developments, organized by technology type - members only
AAPS American Association of Pharmaceutical Scientists
ABA American Bar Association
acceptance criteria The criteria a software product must meet to successfully complete a test phase or to achieve delivery requirements.
ACCP American College of Clinical Pharmacy
accreditation The procedure by which an authoritative body gives formal recognition that a body is competent to carry out specific tasks. [92]
account On LANs or multiuser operating systems, an account is set up for each user. Accounts are usually kept for administrative or security reasons. For communications and online services, accounts identify a subscriber for billing purposes.
(Ref: Dyson, Dictionary of Networking)
ADME/Tox Absorption, Distribution, Metabolism, Excretion - Toxicology
AFNOR Association Francaise de Normalisation. The French Institute for Standardization.
ALADI Association Latino Americana de Integracion. An organization to improve commercial relations with Latin America. Members are Mexico, Argentina, Uruguay, Brazil, Bolivia, Chile, Colombia, Ecuador, Paraguay and Venezuela.
ALGOL Algorithmic-Oriented language
ALMA Analytical Laboratory Manager's Association (ALMA).
An organization in America
alpha(a )-test A verification test performed on a newly implemented system that mimics typical operation and that is performed by company personnel who are not system developers.
American Association of Blood Banks
(AABB)
The AABB sets standards, inspects and accredits blood collection and transfusion facilities, and provides continuing education through programs and newsletters,
American Association of Pharmaceutical Scientists
  • Membership information
  • Meeting schedule
  • Publications
  • Employment opportunities
  • Information for on-line events
  • Software resources
  • Author guidelines
  • Discussion groups broken down by demographic region
American Society of Quality
  • Publishes standards
  • Huge selection of quality related publications
  • Meeting calendars
  • Information about professional certification programs
  • QIC- Quality Information Center - research support for ASQ members (800-248-1946 or e-mail at qic@asq.org.)
  • Links to quality related sites
ANPRM Advanced Notice of Poposed Rulemaking, usually published by the US FDA to get comments from the industry.
ANDA Abbreviated New Drug Application. A simplified submission permitted for a duplicate of an already approved drug. ANDAs are for products with the same or very closely related active ingredients, dose form, strength, administration route, use, and labeling as a product already shown to be safe and effective. An ANDA includes all the information on chemistry and manufacturing controls found in a new drug application (NDA), but does not have to include data from studies in animals and humans. It must, however, contain evidence the duplicate drug is bioequivalent to the previously approved drug. Information concerning the submission of ANDA's can be found in 21 CFR 320
ANSI American National Standards Institute. Official standards body representing the US with the International Organization for Standardization.
AOAC
  • AOAC International is an association of scientists in the public and private sectors devoted to the validation of chemical and microbiological analytical methods and promotion of quality measurements in the analytical sciences.
  • Publications
  • Annual meetings and training courses
  • Industry links
  • Job information
AOAC International AOAC International is an association of scientists in the public and private sectors devoted to the validation of chemical and microbiological analytical methods and promotion of quality measurements in the analytical sciences.
APhA American Pharmaceutical Association
API Active Pharmaceutical ingredient
APIC Active Pharmaceutical Ingredient Comittee
APICS Australian Production and Inventory Control
APR Annual Product Review
APLAC Asia Pacific Laboratory Accreditation Cooperation
APV International Association for Pharmaceutical Technology, located in Germany
German Name: Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik
Application server
A special-purpose file server that is optimized for a specific task, such as communications or a database application, and that uses higher-end hardware than a typical file server.
(Ref: Dyson, Dictionary of Networking)
Application software A program adapted or tailored to the specific requirements of the user for the purpose of data acquisition, data manipulation, data archiving or process control.
AQAP Association of Quality Assurance Professionals
AQC Analytical Quality Control.
ARAMIS Advance Regulatory Affairs Management information
system
ARMA Association of Records Managers and Administrators
ASCII American Standard Code for Information Interchange
ASCPT American Society for Clinical Pharmacology Therapeutics
Assay To provide an exact result which allows an accurate statement on the content or potency of the analyze in a sample (ICH)
ASTM American society for testing and materials. A scientific and technical organization formed for the development of standards on characteristics and performance of materials, products, systems and services.
ASQ American Society for Quality
ASQC
American Society for Quality Control.
ATM

Asynchronous Transfer Mode - A method used for transmitting voice, video, and data over high-speed LANs and WANs. ATM uses continuous bursts of fixed-length packets called cells to transmit data. The basic packet consists of 53 bytes, 5 of which are used for control functions and 48 for data.
ATM is a connection-oriented protocol, and two kinds of connections are possible:

  • Permanent virtual circuits (PVCs), in which connections are created manually
  • Switched virtual circuits (SVCs), in which connections are made automatically

Speeds of up to 2.488Gbps have been achieved in testing. ATM will find wide acceptance in the LAN and WAN arenas as a solution to integrating disparate networks over large geographical distances. Also known as cell relay.
(Ref: Dyson, Dictionary of Networking)

ATP Analytical Target Profile
The Combination of all measurement performance criteria that direct the method development process. An ATP would be developed for each of the attributes defined in the control strategy and defines what a method has to ‘measure and to what level the measurement is required (i.e., performance level characteristics: e.g., precision, accuracy, working range, sensitivity and the associated performance criterion).
AU Absorbance Units
Audit An activity to determine through investigation the adequacy of, and adherence to, established procedures, instructions, specifications, codes, and standards or other applicable contractual and licensing requirements, and the effectiveness of implementation.
Audit tracking A procedural formality built into the operation of a system that ensures all interactions with the system are first authorized before being carried out and then recorded permanently in an operations log.
Audit trail An automatic feature of certain programs or operating systems that creates a running record of all transactions. An audit trail allows you to track a piece of data from the moment it enters the system to the moment it leaves and to determine the origin of any changes to that data.
(Ref: Dyson, Dictionary of Networking)
AUI Application user interface
Authentication In a network operating system or multi-user system, the process that validates a user's logon information.
Authentication may involve comparing the user name and password to a list of authorized users. If a match is found, the user can log on and access the system in accordance with the rights or permissions assigned to his or her user account.
(Ref: Dyson, Dictionary of Networking)
Authorized Person The person recognized by the national regulatory authority as having the responsibility for ensuring that each batch of finished product has been manufactured, tested and approved for release in compliance with the laws and regulations in force in that country.
B
Backbone That portion of the network that manages the bulk of the traffic. The backbone may connect several locations or buildings, and other, smaller networks may be attached to it. The backbone often uses a higher-speed protocol than the individual LAN segments.
(Ref: Dyson, Dictionary of Networking)
Back-end system The server part of a client/server system that runs on one or more file servers and provides services to the front-end applications running on networked workstations. The back-end system accepts query requests sent from a front-end application, processes those requests, and returns the results to the workstation.

Back-end systems may be PC-based servers, superservers, midrange systems, or mainframes.
(Ref: Dyson, Dictionary of Networking)
backup An up-to-date copy of all your files. Your decision when or how often to make a back-up on how frequently important data depends on your system . If you rely on certain files always being available on your system, it is crucial that you make regular, consistent back-ups.
(Ref: Dyson, Dictionary of Networking)
BASIC Beginner's All-Purpose Symbolic Instruction Code
Baud rate In communications equipment, a measurement of the number of state changes (from 0 to 1 or vice versa) per second on an asynchronous communications channel.

Baud rate is often assumed to correspond to the number of bits transmitted per second, but baud rate and bits per second (bps) are not always the same. In high-speed digital communications systems, one state change can be made to represent more than one data bit.
(Ref: Dyson, Dictionary of Networking)
BCR Bureau Communautaire de Reference, Community Bureau of Reference, Commission of the European Community, provides certified reference material
BE bioequivalence
Benchmark A specific standard against which some aspect of computer performance can be compared.

A benchmark is a test that attempts to quantify hardware, software, or system performance--usually in terms of speed, reliability, or accuracy. One of the major problems in determining performance is deciding which of the many benchmarks available actually reflects the way you intend to use the system.
(Ref: Dyson, Dictionary of Networking)
Beta testing The process of field testing new hardware or software products before the product's commercial or formal release. Beta testing is usually done by a cross-section of users, not just programmers. The purpose of beta testing is to expose the new product to as many real-life operating conditions as possible.

If the beta tests indicate a higher-than-expected number of bugs, the developer usually fixes the problems and sends the product out again for another round of beta testing. Preliminary versions of the product documentation are also circulated for review during the beta testing.
(Ref: Dyson, Dictionary of Networking)
Beta(ß)-test A verification test performed at a later stage in implementation, after debugging of the alpha-test version and at the customer's site.
BHMA British Herbal Medicine Association
BIA Biotechnology Industry Association. Represents companies engaged in the development of products and services in the areas of agriculture, biomedicine, diagnostics, food, energy and environmental applications.
Biometrics means a method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable.

Examples are facial recognition, voice recognition and fingerprint scanners. Most of them need specific hardware and software. The biggest problem with these devices is their validation in making sure that they work reliably for the specified user but not for anyone else.
BIRA The British Institute of Regulatory Affairs
Biotechnology Industry Association

Biotechnology Industry Association
"Your link to the Worldwide Biotech lndustry"

  • Very comprehensive site
  • Represents companies engaged in the development of products and services in the areas of agriculture, biomedicine, diagnostics, food, energy and environmental applications.
  • Lists worldwide biotech organizations and their contact information
  • Links to other biotech sites
  • State associations
  • Library/laws and policies
  • Member company profiles and links
  • Industry calendar
  • What's New - Biocareer Center
BLA Biological License Application
Black-box testing A system/software test methodology that is derived from external specifications and requirements of the system. Methods for black-box testing include random testing, testing at boundary values, and a possible error list. It verifies the end results at the system level, but does not check on how the system is implemented. Nor does it assume that all statements in the program are executed. See also functional testing.
BMS
Building Management System.
It is the system that controls and monitors the equipment (HVAC, etc.) used to achieve and maintain the desired environmental conditions in a facility. It also monitors and records those conditions (for example, temperature, humidity, and room pressurization in a manufacturing suite).
BPC Bulp pharmaceutical chemical
BootP BOOTP (Bootstrap Protocol) is a protocol that automatically provides a network user with an IP address and an operating system boot without user involvement. The BOOTP server, man-aged by a network administrator, automatically assigns the IP address from a pool of addresses for a certain time duration. BOOTP is the basis for a more advanced network manager pro-tocol, the Dynamic Host Configuration Protocol (Dynamic Host Configuration Protocol).
Bridge A bridge is a layer 2 local area network (LAN) device that connects two or more LAN segments to effectively make those segments one logical network.
(Ref.: Reeves, Network+)
BRP Business Process Engineering
BRR Batch Record View
British National Formulary (BNF) Guidance on prescribing and notes on drugs and preparations, published jointly by the British Medical Association and the Royal Pharmaceutical Society of Great Britain
British Pharmacopeia (BP) Official compendium of monographs providing authoritative standards for the quality of many substances, preparations and articles used in medicine and pharmacy. It incorporates monographs of the European Pharmacopeia. It is a legally enforceable document throughout most of the Commonwealth and many other countries.
BPI Association of the German Pharmaceutical Industry
bug A manifestation of an error in software.
bus

An electronic pathway along which signals are sent from one part of a computer to another. A PC contains several buses, each used for a different purpose:

  • The address bus allocates memory addresses.
  • The data bus carries data between the processor and memory.
  • The control bus carries signals from the control unit.

(Ref: Dyson, Dictionary of Networking)

BSI
British Standards Institution.
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