Home | Contact Us | Newsletter | Usersclub | Books | Audio Seminars

Glossary U - Z

UCITA Uniform Computer Information Transactions Act
UETA Uniform Electronic Transaction Act
UKAS 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 Bodies (NACCB)
Uncertainty 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)
UNDCP United Nations International Drug Control Programs
URL Uniform resource locator. Tool used to identify sites on the Internet.
URS see User Requirement Specification.
User interface prototyping A verification test for software performed on design phase subsystems to check that operational concepts are grasped by the operators.
User Requirement Specification Typically the first step of validation. URS defines what the user wants to do with a product
USP 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.
VAC PHARMA's Validation Advisory Committee
VAI Voluntary Action Indicated. Observation category in FDA's establishment inspection reports
Validation Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes
Validation protocol Written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment, and decision points on what constitutes acceptable test results.
VBA 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)
VFA Verband Forschender Arzneimittelhersteller e. V (Germany)
Verification Confirmation by examination and provision of evidence that specified requirements have been met
VFA Verband Forschender Arzneimittelhersteller e. V (Germany)
Virus 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).
VMP Validation master plan. Demonstrates a companies approach for validation. Improves efficiency and consistency for validation.
VSD 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 successfully exploited.

WAN 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)
Warning Letters
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.
WEP 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 encryption.
Western European 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 Switzerland.
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.
WHO World Health Organization
WINS 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.
WL Warning Letter
W-LAN Wireless Local Area Network
Workbook 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.
Working solution 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.
Worm 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.
WORM 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.
Worst case 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.
Wrapper Refers to a third party application which adds the missing elements required by part 11
WWW 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.
XML 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.
... ...
... ...
... ...