| 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) |
| 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.
|
| |
|
| 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) |