||Uniform Computer Information Transactions Act
||Uniform Electronic Transaction Act
||United Kingdom Accreditation Service. The
national accreditation body for the UK. Formed in 1995 by the
amalgamation of the National Measurement Accreditation service
(NAMAS) and the National Accreditation Council for Certification
||Measurement uncertainty is an estimate to a
measurement which characterizes the range of values within which the
true value is asserted to lie (ISO/DIS 254-1)
||United Nations International Drug Control
||Uniform resource locator. Tool used to identify
sites on the Internet.
||see User Requirement Specification.
||A verification test for software performed on
design phase subsystems to check that operational concepts are
grasped by the operators.
||Typically the first step of validation. URS
defines what the user wants to do with a product
||United States Pharmacopoeia (USP) Official
compendium recognized by the Federal Food, Drug, and cosmetic Act.
Serves as the basis for enforcement actions by the U.S. Food and
Drug Administration involving official (USP) drugs. Published every
five years by the United States Pharmacopoeia Convention, a
non-profit organization. It is combined with the National Formulary.
The USP is the official pharmacopoeia of the United States and
several other countries.
||PHARMA's Validation Advisory Committee
||Voluntary Action Indicated. Observation
category in FDA's establishment inspection reports
||Establishing documented evidence that provides
a high degree of assurance that a specific process will consistently
produce a product meeting its predetermined specifications and
||Written plan stating how validation will be
conducted, including test parameters, product characteristics,
production equipment, and decision points on what constitutes
acceptable test results.
||Visual Basic for Applications. Microsoft’s
common application scripting language for MS office applications.
Has very little in common with early versions of BASIC (Beginner’s
All-purpose Symbolic Instruction Code)
||Verband Forschender Arzneimittelhersteller e. V
||Confirmation by examination and provision of
evidence that specified requirements have been met
||Verband Forschender Arzneimittelhersteller e. V
||A program intended to damage a computer system
without the user's knowledge. A virus clones itself from disk to
disk or from system to system over a network. A virus may attach
itself to a program table or boot track on a hard disk (Ref: Dyson,
Dictionary of Networking).
||Validation master plan. Demonstrates a
companies approach for validation. Improves efficiency and
consistency for validation.
||Validation Strategy Document. Equivalent to a
Validation Plan but different from the Validation Protocol
|A security exposure or misconfiguraiton in an
operating system or other system software or application software
component that allows the security policy to be violated. A variety
of organizations maintain publicly accessible databases of
vulnerabilities based on version number of the software. Much
vulnerability can potentially compromise the system or network if
||Wide Area Network - A network that connects
users across large distances, often crossing the geographical
boundaries of cities or states.
(Ref: Dyson, Dictionary of Networking)
|The purpose of a warning letter is to notify
the firm’s senior management that the company is in violation of the
law and that FDA is ready to take regulatory action if voluntary
corrections are not accomplished. For computer validation, warning
letters are usually issued as a result of a field investigator’s
FD-483 observation in which a computer system used to ensure the
quality of a product is found to be deficient. In most cases,
warning letters are issued by an FDA center compliance office. The
letters signify concurrence by the FDA field and headquarters staff
and are therefore excellent resources for identifying current agency
policy and expectations. As with FDA-483 observations, it is
important to look at trends when reviewing these documents.
||Wireless encryption protocol. Help to ensure
that only authorized users attach to the network to begin with,
regardless of their ability to authenticate to network devices.
Without WEP anyone can see the packets sent across the network, and
those packets can include passwords. Work with 128 or 256 bit
Laboratory Accreditation Corporation (WELAC)
||Formed in 1989 to represent the interests of
laboratory accreditation bodies in Western Europe. Deals with
accreditation of test laboratories for European recognition by their
clients. Established through a Memorandum of Understanding (MOU) for
multilateral recognition of accredited laboratories. Evaluates
accreditation and certification bodies for European recognition of
test laboratories accredited by the accreditation body. Also has
contacts with the OECD on the relationship between GLP and EN 45001.
Audits accreditation bodies in Europe, for example, the EAM in
Will be combined with the WECC in 1994. Developed and signed a
contract with the EOTC for EC wide recognition of accreditation
systems (May 13, 1992).
|White box testing
||A software test methodology at the module level
in which test cases are derived from the internal structure of the
programs. It may execute all the statements or branches in the
program to check on how the system is implemented.
||World Health Organization
||Windows Internet Name System (WINS) servers are
similar to DNS servers but are updated automatically. This
technology gives each computer an address automatically every time
it boots, making it easy to find on the network.
||Wireless Local Area Network
||One of the most common Excel object. Everything
you do in Excel takes place in a workbook which is stored in a file
with xls extension. An Excel workbook can hold any number of sheets.
Most important are worksheets and chart sheets.
||Solution prepared from the stock solution
through dissolution in the appropriate solvent.
|Most common type of Excel sheet. Every Excel
worksheet has 256 columns and 65,536 rows. Multiple worksheets in a
workbook enable you to organize your work better.
||A type of malicious code particular to
networked computers. It is a self-replicating program (unlike a
virus which needs a host program) which works its way through a
computer network exploiting vulnerable hosts, replicating and
causing whatever damage it was programmed to do.
||1) Write once, read many. An optical disk drive
with huge storage capacity. The disk becomes a read-only storage
medium after data is written to the disk.
||1) A set of conditions encompassing upper and
lower processing limits and circumstances, including those within
standard operation procedures that pose the greatest chance of
process or product failure when compared to ideal conditions. Such
conditions do not necessarily induce product or process failure.
2) The highest or lowest boundary value of a given control parameter
actually established in a validation qualification exercise.
||Refers to a third party application which adds
the missing elements required by part 11
||World Wide Web. Collection of pages that can be
published by anyone and can be viewed by millions of Internet users.
The Web is the most popular method of distributing information
through the internet.
||1) Extensible Markup Language (controlled by
worldwide web consortium)
2) Excel’s Macro Language before version 5. Later versions of Excel
still execute XML macros but can not record any more.