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Glossary R - T

R
RAID Redundant array of inexpensive disks. In network and mission critical applications, a method of using several hard disk drives in an array to provide fault tolerance in the event that one or more drives fails.
RAPS
  • Certification - download applications guide to certifications
  • Coming soon:
  • Search all Regulatory Affairs Focus articles in 1997 and 1998 by topic, author or date
  • On-line shopping:
  • Purchase online or downloaded selected documents at no charge (available to members only)
  • Also has Internet discussion forums (not yet available)
  • RAPS:
  • Provide links to Regulatory Agencies all over the world - Czech Republic, EU, MCA, MDA, Finnish Institute of Occupational Health
  • And much more
  • Certification
Raw data Any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities of a non clinical laboratory study and are necessary for the reconstruction and evaluation of the report of that study. It may include photographs, microfilm or microfiche copies, computer printouts (not for electronic records systems), magnetic media, including dictated observations, and recorded data from automated instruments.
Recovery The extraction efficiency of an analytical process, reported as a percentage of the known amount of an analyte carried out through the sample extraction and processing steps of the procedure.
Records All documents that provide evidence of what you were going to do, that you did it, and what happened when you had done it.
Redirector Software loaded on Microsoft Windows 95 or NT workstation used to direct requests from the application to the network. If an application saves a file, for example, the redirector decides if the request is for a local drive or for a drive mapped on the network.
Reference material A material or substance, one or more properties of which are sufficiently well established to be used for calibrating an apparatus, assessing a measurement method or for assigning values to materials
Reference standard A standard, generally of the highest metrological quality available at a given location, from which measurements made at that location are derived.
Registration A procedure by which a body indicates relevant characteristics of a product, process or service, or particulars of a body or person, in an appropriate, publicly available list.
Regression testing Rerunning test cases which a program has previously executed correctly in order to detect errors spawned by changes or corrections made during software development and maintenance (FDA part 11 guide: glossary of terms, draft)
Regulatory Compliance Information Center

Broken down into the following categories:

  • Testing Labs
  • Compliance Products
  • Compliance Colleagues
  • Regulations and Standards
  • Consulting Companies
  • Site includes much information on electronics
Regulatory methods validation Process whereby submitted analytical procedures are first reviewed for adequacy and completeness and then are tested as deemed necessary in U.S. Food and Drug Administration laboratories. Depending in part on the quality of submitted data, validation may range from step-by-step repetition of an assay procedure to more elaborate studies that include assessment of accuracy, precision, sensitivity, and ruggedness of the method.
Relacre RELACRE is the Portuguese member of EUROLAB
REMCO Council Committee of Reference Materials of the International Organization for Standardization, established in 1976. The committee has since published several guides on the nomenclature, certification and uses of reference materials.
Resource 1. Any part of a computer system that can be used by a program as it runs. Resources include memory, hard and floppy disks, networking components, the operating system, printers, and other output devices, as well as queues, security features, and other less well defined data structures.

2. In HTML, any URL, directory, or application that the server can access and send to a requesting client.

(Ref: Dyson, Dictionary of Networking)
Repeater A repeater is a device that is added to a network to extend the signal on the cable. As a signal travels the length of the cable, it tends to loose strength or attenuate. A repeater compensates for this attenuation, reconstructs the signal and transmits it to the network. A hub functions as a multi-port repeater which it does by repeating the signal on all ports within the collision domain. (Ref.: Reeves, Network+)
Reproducibility Precision between laboratories
Resource 1. Any part of a computer system that can be used by a program as it runs. Resources include memory, hard and floppy disks, networking components, the operating system, printers, and other output devices, as well as queues, security features, and other less well defined data structures.

2. In HTML, any URL, directory, or application that the server can access and send to a requesting client.

(Ref: Dyson, Dictionary of Networking)
Retrospective validation Rerunning test cases which a program has previously executed correctly in order to detect errors spawned by changes or corrections made during software development and maintenance
Revalidation A repetition of validation necessary after the process has been changed, for example, when a manual system is upgraded to an automated system.
Reverse DNS Reverse DNS (rDNS) is a method of resolving an IP address into a domain name, just as the domain name system (DNS) resolves domain names into associated IP addresses. One of the applications of reverse DNS is as a spam filter. Here's how it works: Typically, a spammer uses an invalid IP address, one that doesn't match the domain name. A reverse DNS lookup program inputs IP addresses of incoming messages to a DNS database. If no valid name is found to match the IP address, the server blocks that message.

Although reverse DNS is fairly effective for filtering spam, it also sometimes blocks valid e-mail, at least in the current technological environment. A number of problems, including network delays and improperly configured networks or servers, can prevent legitimate messages from getting through the filter. In January 2003, AT&T WorldNet started using reverse DNS in conjunction with other anti-spam software. The company was forced to remove the filter just 24 hours after it was deployed, after subscribers reported that messages were going undelivered
Reverse Lookup: Definition: is the determining of the host name from the IP address. The course of queries is similar to forward lookups using part of the IP address to find out what machines are responsible for what ranges of IP address.
RFI Radio Frequency Interference - Many electronic devices, including radios, televisions, computers, and peripherals, can interfere with other signals in the radio-frequency range by producing electromagnetic radiation. The use of radio frequencies is generally regulated by government agencies.
(Ref: Dyson, Dictionary of Networking)
RFP Request for Proposal
RL Reporting Limit (Term used for method validation)
Risk mitigation Planning process in which you try to think of ways to prevent your identified risk from ever occurring, while at the same time coming up with a means of recovery should the risk become a reality in spite of all efforts.
RMS Reference Member State
Router

An intelligent connecting device that can send packets to the correct LAN segment to take them to their destination.

  • Routers link LAN segments at the network layer of the OSI Reference Model for computer-to-computer communications. The networks connected by routers can use similar or different networking protocols.
  • A router may be one or more of the following types:
    Central Acts as a network backbone, connecting many LANs.
  • Peripheral Connects individual LANs to either a central router or to another peripheral router.
    Local Operates within its LAN driver's cable-length limitations.
  • Remote Connects beyond its device driver limitations, perhaps through a modem or remote connection. Internal Part of a network file server.
    External Located in a workstation on the network.

    (Ref: Dyson, Dictionary of Networking)
RSS The term RSS refers to a syndication format, sometimes known as Really Simple Syndication or Rich Site Summary. Each RSS feed is simply a text document containing a list of content items. The text document contains the headline, description and link for content items available on a web site.
RTF Rich Text Format
Ruggedness An indication of how resistant the process is to typical variations in operation, such as those to be expected when using different analysts, different instruments and different reagent lots. Required under GLP guidelines.
RUP Rational Unified Process® (used for software development)
S
SAE Serious Adverse Events
Drug safety reporting systems
SAN Storage Area Network
SANS SANS Institute (Systems Administration Networking and Security). One of the "big three" professional certification organizations for information security professionals.
SARAC Southern African Regional Accreditation Cooperation
SAT Site Acceptance Testing
SAV/SSPh Swiss Soc. of Pharmacy
SC Supply Change
SCADA Supervisory Control and Data Acquisition Systems
SDLC Software development lifecycle or System development lifecycle
The progression of phases in the life of a software/system project, e.g., Planning, Design, Coding, Testing, Maintenance.
Server Any computer that makes access to files, printing, communications, and other services available to users of the network.

In large networks, a dedicated server runs a special network operating system; in smaller installations, a non-dedicated server may run a personal computer operating system with peer-to-peer networking software running on top.

A server typically has a more advanced processor, more memory, a larger cache, and more disk storage than a single-user workstation. A server may also have several processors rather than just one and may be dedicated to a specific support function such as printing, e-mail, or communications. Many servers also have large power supplies, UPS (uninterruptible power supply) support, and fault-tolerant features, such as RAID technology.

On the Internet, a server responds to requests from a client, usually a Web browser.
(Ref: Dyson, Dictionary of Networking)
Service desk Single point of contact with customers.
Service Pack A software patch that is applied to an installed application. It is either downloaded from the vendor’s website or distributed via Compact Disk-Read Only Memory (CD-ROM). When executed, it modifies the application in place.
SGML Standard generalized markup language
SI System International
SIG Special Interest Group
Single sign on Single sign-on (SSO) is a session/user authentication process that permits a user to enter one name and password in order to access multiple applications. The process authenticates the user for all the applications they have been given rights to and eliminates further prompts when they switch applications during a particular session.

For example, suppose you log on to a Novell network with your Novell username and password. Single sign-on would be where your PW/User ID are stored for other systems, say a chromatographic data system system for example. So you don't need to logon to this CDS application to access it since the PW/ID were provided when you initially logged on to the network.
Sinal National Accreditation System for Laboratories in Italy
Sincert Italian National System for the Accreditation of Certification Bodies. Has been established, in the form of an Association, on the initiative of UNI (Italian National Standards Body) and CEI (Italian Electrotechnical Committee), and with the support of the Ministry of Industry, Trade and Handicraft, the CNR (National Research Council), ENEA (National Committee for Research and Development in Nuclear Power and Alternative Energy Sources) and the Chambers of Commerce
SLA Service level agreement. Document (drafted either a contract or similar to a contract) that provides a defined standard for service. An SLA helps to protect customers and service providers. For example, in the case of a help desk or customer service center, an SLA might define customer service hours, the level of support provided, and a normal response time. An SLA between a customer site and a telecommunications provider might define maintenance windows, acceptable limits for outage periods , and a minimum quality or level of service (Ref: L. Miller, Security + Certiification, Wiley Publishing)
SME Small and Medium-sized Enterprise
SMF Site Master File
SMTP Simple Mail Transfer Protocol gateway. Main e-mail transport for the Internet e-mail. Uses Domain Name System (DNS) addressing to deliver the mail to the correct location throughout the Internet.
SNMP Simple Network Management Tool. Use to read and write (set) information on network devices.
Source code An original computer program in a legible form (programming language), translated into machine-readable form for execution by the computer.
SPC Statistical Process Control
Spreadsheet application Spreadsheet file or group of related files that is designed so that someone other than the programmer can perform useful work without training
SQ Specification Qualification
SQL Structured Query Language
Substantive rule A substantive rule is a regulation that carries the force and effect of law
SUPAC Scale Up and Post Approval Changes
SST System Suitability Test
Standard Operating Procedure (SOP) Documented instructions that should be followed when operating a process for the process to be considered valid. Required under GLP regulations. Written documents that prescribe the detailed methods and action steps to be followed in order to accomplish a particular task. The U.S. Food and Drug Administration requires SOPs for virtually every aspect of production, control and testing of pharmaceutical products. One of the SOPs should describe the issuance and control of SOPS.

The United Kingdom Guide to Good Pharmaceutical Manufacturing Practices defines SOPs as written authorized procedures that give instructions for performing operations not necessarily specific to a given product or material, but of a more general nature (equipment operation, maintenance and cleaning, cleaning of premises and environmental control, sampling and inspection, etc.).
Stock solution The original solution prepared directly by weighing the reference standard of the analyte and dissolving it in appropriate solvents.
Structural testing Examining the internal structure of the source code. Includes low-level and high-level code review, path analysis, auditing of programming procedures and standards actually used, inspections for extraneous "dead code", boundary analysis and other techniques. Requires specific computer science and programming expertise.

FDA Part 11 validation guidance (draft): Structural testing: this testing takes into account the internal mechanism (structure) of a system or component. It is sometimes referred to as "white box" testing. Structural testing should show that the software creator followed contemporary quality standards (e.g., consensus standards from national and international standards development organizations, such as those listed in Appendix A of this guidance). This testing usually includes inspection (or walk-throughs) of the program code and development documents.
Subnet mask This feature partitions the network into segments. It is the way a router knows if a packet sent stays on the local network or needs to be passed to a different network.
Superuser

A special Unix privilege level, with unlimited access to all files, directories, and commands.

The system administrator must become the superuser to perform certain functions, such as creating new accounts, changing passwords, and other administrative tasks that ordinary users are not allowed to perform for security reasons. The superuser's login name is usually root, with a user ID of 0.
(Ref: Dyson, Dictionary of Networking)

System

Comprises the analytical equipment and the method used on that equipment. A system of computerized equipment also includes the computer and software (including all mathematical operations performed on the measurement data).

System life cycle

The period of time that starts when a software product is conceived and ends when the product is no longer available for use. The software life cycle typically includes a requirements phase, design phase, implementation phase, test phase, installation and checkout phase and operation and maintenance phase.

System suitability testing

A process of checking out the performance specifications of a system, often called method validation when applied to a particular separation and called system validation when applied to a separation system used routinely.

   
T
TGA (Australia) Therapeutic Goods Administration
(US FDA)
Talk Papers

The FDA press office prepares talk papers to guide agency personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. They provide additional insight on FDA’s activities.

TCP
  • Transmission control protocol - The transport-level protocol used in the TCP/IP suite of protocols. It works above IP in the protocol stack and provides reliable data delivery over connection-oriented links. TCP adds a header to the datagram that contains the information needed to get the datagram to its destination.
  • The source port number and the destination port number allow data to be sent back and forth to the correct processes running on each computer. A sequence number allows the datagrams to be rebuilt in the correct order in the receiving computer, and a checksum verifies that the data received is the same as the data sent. In addition to these fields, the TCP header contains the following information:
  • Acknowledgment number Indicates that the data was received successfully. If the datagram is damaged in transit, the receiver discards the data and does not send an acknowledgment to the sender. After a specified timeout expires, the sender retransmits data for which no acknowledgment has been received.
  • Offset Specifies the length of the header.
    Reserved Variables set aside for future use.
    Flags Indicate that this packet is the end of the data or that the data is urgent.
  • Window size Provides a way to increase packet size, which can improve efficiency in data transfers.
    Urgent pointer Gives the location of urgent data.
    Options Reserved for future use or for special options as defined by the protocol.
  • Padding Ensures that the header ends on a 32-bit boundary.

The data immediately follow this header information.
(Ref: Dyson, Dictionary of Networking)

TCP/IP Transmission control protocol / Internet Protocol - Abbreviated TCP/IP. A set of communications protocols first developed by the Defense Advanced Research Projects Agency (DARPA) in the late 1970s. The set of TCP/IP protocols encompasses media access, packet transport, session communications, file transfer, e-mail, and terminal emulation.

TCP/IP is a widely published open standard, and while completely independent of any specific hardware or software company, it is supported by a huge number of vendors and is available on many different computers, from PCs to mainframes, running many different operating systems. Many corporations, universities, and government agencies use TCP/IP, and it is also the basis of the Internet.
(Ref: Dyson, Dictionary of Networking)
TGA (Australian) Therapeutic Goods Administration
Test A technical operation that consists of the determination of one or more characteristics or performance of a given product, material, equipment, organism, physical phenomenon, process or service according to a specified procedure
Test plan A document prescribing the approach to be taken for intended testing activities. The plan typically identifies the items to be tested, the testing to be performed, test schedules, personnel requirements, reporting requirements, evaluation criteria and any risks requiring contingency planning.
Token Ring network IBM's implementation of the token-ring network architecture, which uses a token-passing protocol transmitting at 4 or 16Mbps.

Using standard telephone wiring, a Token Ring network can connect a maximum of 72 devices; with shielded twisted-pair (STP) wiring, each ring can support a maximum of 256 nodes. Although it is based on a closed-loop ring structure, a Token Ring network uses a star-shaped cluster of as many as eight nodes, all attached to the same wiring concentrator or Multistation Access Unit (MAU). The MAUs are then connected to the main ring circuit. A Token Ring network can include personal computers, minicomputers, and mainframes. The IEEE 802.5 standard defines token-ring networks.
(Ref: Dyson, Dictionary of Networking)
Traceability The property of a result of a measurement whereby it can be related to appropriate standards, generally international or national standards, through an unbroken chain of comparisons all having stated uncertainties
Transceiver A transceiver converts one type of media topology to an other type while maintaining the integrity of the network signal.
Transaction A single activity within a computer system, such as an entry into an airline reservation database, that is executed in real time rather than as a batch process.
(Ref: Dyson, Dictionary of Networking)