| 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)
|
| 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. |
| 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. |