| CADREAC |
Callaboration Agreement of Drug Regulatory
Authorities in European Associated Countries |
| Calibration |
1) The set of operations that establish, under
specified conditions, the relationship between values indicated by a
measuring instrument or measuring system, or values represented by
material measure and the corresponding values of the measured. Used
by regulatory agencies to refer to the process of checking or
adjusting instruments (including analytical instruments). Also used
in chromatography to refer to the process of using standard samples
as part of method verification.
2) Calibration An operational check that generally involves the use
of standard materials or test instruments that have certification
traceable to the National Technical Information Service (formerly
the National Bureau of Standards). |
| CAMA |
Computer Assisted Marketing Authorization
Application |
| CAMD |
Computer Assisted Molecular Design |
| CAMM |
Computer Assisted Molecular Modeling |
| CANDA |
Computer-Assisted New Drug Application |
| CANDS |
Computer Assisted New Drug Submission |
| CAPA |
Corrective and preventive action plan. Required
for FDA compliance in case of specification situations or other
deviations. |
| CAS |
Chemical Abstracts Service |
| CASE |
Computer aided software engineering |
| CDC |
Centers of Disease Control and Protection |
| CDER |
Center for Biologics Evaluation and Research |
| CDER |
Center for Drug Evaluation and Research |
| CDRH |
Center for Devices and Radiological Health |
| CD-ROM |
Compact disk, read only |
| CD-RW |
Compact disk, rewritable |
| CDS |
Chromatography Data System |
| CE |
Capillary Electrophoresis |
| CEN |
Comite Europeen de Normalisation. The committee
on European standardization. Its members are the national standards
organizations of EC and EFTA countries. |
| CEN/CENELEC |
Comité Européen de Normalisation/Electrotechnical
Standardization: The joint European Standards Institution. Develops
norms such as EN 45000 series. |
| CENSA |
Collaborative Electronic Notebook Systems
Association. It is an international industry association, focused on
driving the state of the art for electronic recordkeeping systems
and collaborative technologies wherever they are used, with an
emphasis on pharmaceutical and chemical needs. Their website has a
section called CENSA Weblinks, which leads to many other sites that
are focused on technologies that are relevant in light of the FDA's
rule. |
| CEP |
Certificate European Pharmacopoeia |
| Certification |
Procedure by which a third party gives written
assurance that a product, process or service conforms to specified
requirements.
1. Documented review and approval of all qualification and
validation documentation prior to release of the design production.
2. Documented review and approval process performed as the final
step in a validation program to permit product release.
3. Requirement that each manufacturer of an electronic product
certify that it conforms to all applicable standards. |
| Certified copy |
Means a copy of original information that has
been verified, as indicated by dated signature, as an exact copy
having all of the same attributes and information as the original. |
| Certified reference
material (CRM) |
Reference material, accompanied by a
certificate, one or more of those property values are certified by a
procedure which establishes its traceability to an accurate
realization of the unit in which the property values are expressed,
and for which each certified value is accompanied by an uncertainty
at a stated level of confidence (ISO Guide 30:1992) |
| CFR |
US Code of Federal Regulation |
| CMC |
Chemistry for Manufacturing Controls |
| CMC CC |
Chemistry for Manufacturing Controls
Coordinating Committee of the Center of Drug Evaluation and Research |
| cGMP |
Current Good Manufacturing Practice. |
| Change control |
A procedural formality required for validation,
defining how and when changes may be made and in which situations
revalidation is required. |
| CITAC |
Co-Operation on International Traceability in
Analytical Chemistry. A forum for worldwide cooperation
collaboration on the mechanisms needed to ensure the validity and
comparability o analytical data on a global basis. |
| Checksum |
A method of providing information for error detection, usually
calculated by summing a set of values.
The checksum is usually appended to the end of the data that it
is calculated from so that they can be compared. For example, Xmodem,
a popular file-transfer protocol, uses a 1-byte checksum calculated
by adding all the ASCII values for all 128 data bytes and ignoring
any numeric overflow. The checksum is added to the end of the Xmodem
data packet. This type of checksum does not always detect all
errors. In later versions of the Xmodem protocol, cyclical
redundancy check (CRC) is used instead for more rigorous error
control.
(Ref: Dyson, Dictionary of Networking)
If files are transferred tough the Internet, the checksum can be
sent with the file and re-calculated at the receiving site. It also
is useful to very correct file migration from one media to an other
one. Including a checksum for each individual file provides a number
of benefits including:
- The integrity of each file can be verified by comparing the
checksum submitted with the file and the computed checksum.
- The checksum can be used to verify that the file has not
been altered in the historical archive of the regulatory
authority. This is especially useful as the files are migrated
from one storage medium to another, as in the case of backup to
magnetic tape storage.
|
| Class A network |
In the IP addressing scheme, a very large
network. The high-order bit in a Class A network is always zero,
leaving 7 bits available to define 127 networks. The remaining 24
bits of the address allow each Class A network to hold as many as
16,777,216 hosts. Examples of Class A networks include General
Electric, IBM, Hewlett-Packard, Apple Computer, Xerox, Digital
Equipment Corporation, and MIT. All the Class A networks are in use,
and no more are available.
(Ref: Dyson, Dictionary of Networking) |
| Class B network |
In the IP addressing scheme, a medium-sized
network. The 2 high-order bits are always 10, and the remaining bits
are used to define 16,384 networks, each with as many as 65,535
hosts attached. Examples of Class B networks include Microsoft and
Exxon. All Class B networks are in use, and no more are available.
(Ref: Dyson, Dictionary of Networking) |
| Class C network |
In the IP addressing scheme, a smaller network.
The 3 high-order bits are always 110, and the remaining bits are
used to define 2,097,152 networks, but each network can have a
maximum of only 254 hosts. Class C networks are still available.
(Ref: Dyson, Dictionary of Networking) |
| Class D network |
In the IP addressing scheme, a special
multicast address that cannot be used for networks. The 4 high-order
bits are always 1110, and the remaining 28 bits allow access to more
than 268 million possible addresses.
(Ref: Dyson, Dictionary of Networking) |
| Class E network |
In the IP addressing scheme, a special address
reserved for experimental purposes. The first 4 bits in the address
are always 1111.
(Ref: Dyson, Dictionary of Networking) |
| Client |
A device or application that uses the services
provided by a server.
A client may be a PC or a workstation on a network using services
provided from the network file server, or it may be that part of an
application program that runs on the workstation supported by
additional software running on the server.One of the most familiar
clients is the Web browser.
(Ref: Dyson, Dictionary of Networking) |
| Client server-based
networking applications |
Typically refers to software where processing
is split between a server application and a client application. The
server application (which normally resides on a more powerful
machine) is located centrally and responds to requests from the
client applications. The data, print queues, data back-up, shared
modems, and security are stored on the central server, such as
Windows NT, Novel or Unix. The client workstations connect to the
server and receive a security log-in prompt. The advantages of a
server based network are ease of management and central control of
critical data. |
| Closed system |
An environment in which system access
controlled by persons who are responsible for the content of
electronic records that are on the system. |
| CMC |
Chemistry Manufacturing and Control |
| CMR |
Committee for Medical Research |
| COA |
Certificate of analysis |
| COBOL |
Common business orientated language |
| Code of Federal
Regulations (CFR) |
Collection of all regulations issued by U.S.
government agencies. The individual titles making up the regulations
are numbered the same way as the federal laws on the same topic. For
example, the Federal Food, Drug, and Cosmetic Act is found in Title
21 of United States Code and the companion regulations implementing
the law are found in 21 CFR. |
| Collision |
A collision results when two devices attempt to
transmit data at exactly the same time and are discarded. An
Ethernet network uses Carrier Sense Multiple Access/Collision Detect
(CSMA/CD) to allow devices to take turns using the signal carrier
line. When a device wants to transmit, it checks the signal level of
the line to determine whether someone else is already using it. If a
line is in use, the device waits and retries. If the line is not in
use, the device transmits. |
| COMAR |
Code d’Indexation des Materiaux de Reference,
International database for registering reference material. Joinz
enterprise between the Laboratoire National d’Essais (Paris,
France), the Bundesanstalt fuer Materialforschung und Pruefung
(Berlin, Germany) and National Physical Laboratory (Teddington,
Great Britain) |
| Compliance |
A state of laboratory operations that ensures
activities follow documented protocols. GLP compliance is the
responsibility of the study director who oversees the facility, the
personnel, the materials and the equipment or subcontractors that
fall under the compliance protocols. A particular instrument is only
GLP compliant when validated and verified by the operator for the
specific analysis to be performed. A vendor cannot claim GLP
compliance for its products. |
| Commit |
Means a saving action, which creates or
modifies, or an action which deletes, an electronic record or
portion of an electronic record. An example is pressing the key of a
keyboard that causes information to be saved to durable medium. |
| (US FDA) Compliance
Policy Guides |
The purpose of the CPGs manual is to provide a
convenient and organized system for statements of FDA compliance
policy, including those statements that contain regulatory action
guidance information. The CPGs also advise field inspection and
compliance staffs on the agency’s standards and procedures to be
applied when determining industry compliance with the regulations. |
| Computer account |
In Microsoft Windows 2000, an object in the
Security Accounts Manager that describes a specific computer within
a network domain. A computer account is added for each node added to
the domain.
(Ref: Dyson, Dictionary of Networking) |
| Computer system |
A system composed of computer(s), peripheral
equipment such as disks, printers and terminals, and the software
necessary to make them operate together (ANSI/IEEE Standard
729-1983). |
| Computerized system |
A system that has a computer as a major,
integral part. The system is dependent on the computer software to
function |
| Computer-related system |
Computerized system plus its operating
environment. |
| Computer Validation
Initiative Committee (CVIC) |
The CVIC is an Society for Quality Assurance
(SQA) committee that is a standing, proactive working group serving
as a resource for the needs of the SQA membership, concentrating
specifically on the computer validation role of the QA professional.
Mission: To provide current industry perspectives on Computer
Validation Issues for the QA professional.
Goals: 1) Identify pressing computer validation issues, 2) Develop
strategies to deal with these issues, 3) Define reasonable
expectations with regard to computer validation with the regulatory
agencies, 4) Provide education and training for SQA members |
| Configuration management |
A term covering a wide range of network administration tasks,
often performed by the network administrator, including:
- Maintaining a hardware database containing details of
routers, bridges, and connections so that changes in the network
can be made quickly in the event of a failure
- Adding and removing workstations and users to the network as
needed
- Adding and configuring new servers and cabling systems as
the network expands
(Ref: Dyson, Dictionary of Networking)
|
| Consent decree |
Status imposed by the FDA in serious violation
of federal regulations and related safety and quality standards. A
company must agree to a series of measures aimed at bringing it's
manufacturing standard into compliance with federal regulations.
Until agreed-upon conditions are met, a company may be forbidden to
distribute its products in interstate commerce, except for those
products deemed essential for the public health. Reference: the
Biopharm guide to BioTerminology |
| Control charts |
Routine charting of data obtained from analysis
of standards or (certified) reference material to check that the
results lie within predetermined limits |
| COTS |
Commercial off-the-shelf (software, computer
systems) |
| CQ |
Construction specification. Ensures materials
are suitably manufactured to required specifications |
| CPG |
FDA Compliance Policy Guide |
| CPMG |
Committee for proprietary medicinal products
(CPMP) in Europe |
| CPMP |
Committee for Proprietary Medicinal Products |
| CRO |
Contract Research Organisation |
| CROMERR |
Cross Media Recordkeeping and Record Retention
Rule |
| Crossover cable (pix) |
A twisted pair cable used only for a direct
connection between a gas chromatograph and the PC network interface
card (Agilent part number 5183-4649). |
| CSMA/CD |
Carrier Sense Multiple Access/Collision Detect
(CSMA/CD) is the protocol for carrier transmission access in
Ethernet networks. See "collision" for a detailed explanation. |
| CSPS |
Canadian Society for Pharmaceutical Sciences |
| CSVC |
PMA’s Computer system validation committee |
| CSV |
Computer system validation |
| CTA |
Clinical Trial Application |
| CTC |
Clinical Trial Certificate |
| CTD |
Common Technical Document |
| CU |
Content Uniformity |
| CVM |
Center for Veterinary Medicine |
| CVMP |
Committee for veterinary medicinal products in
Europe |
| DAB |
Deutsches Arzneimittelbuch, German equivalent
of USP (United States Pharmacopoeia) |
| DAT |
Digital audio tape |
| Database server |
Any database application that follows the
client/server architecture model, which divides the application into
two parts: a front-end running on the user's workstation and a
back-end running on a server or host computer. The front-end
interacts with the user and collects and displays the data. The
back-end performs all the computer-intensive tasks, including data
analysis, storage, and manipulation.
(Ref: Dyson, Dictionary of Networking) |
| Data packet |
One unit of information transmitted as a
discrete entity from one node on the network to another. More
specifically, a packet is a transmission unit of a fixed maximum
length that contains a header with the destination address, a set of
data, and error control information.
(Ref: Dyson, Dictionary of Networking) |
Data-transfer rate
|
The speed at which a disk drive can transfer
information from the drive to the processor, usually measured in
megabits or megabytes per second.
1. The rate of information exchange between two systems. For
example, an Ethernet LAN may achieve 10Mbps, and a Fiber Distributed
Data Interface (FDDI) system may reach 100Mbps.
(Ref: Dyson, Dictionary of Networking) |
| Data validation |
A process used to determine if data are
inaccurate, incomplete, or unreasonable. The process may include
format checks, completeness, checks, check key tests, reasonableness
checks, and limit checks. |
| DBMS |
Database management system |
| DCS |
Distributed control system |
| DDE |
Dynamic Data Exchang - A technique used for
application-to-application communications, available in several
operating systems, including Microsoft Windows, Macintosh, and OS/2.
When two or more programs that support DDE are running at the same
time, they can exchange data and commands, by means of
conversations. A DDE conversation is a two-way connection between
two applications, used to transmit data by each program alternately.
DDE is used for low-level communications that do not need user
intervention. For example, a communications program might feed stock
market information into a spreadsheet program, where that data can
be displayed in a meaningful way and recalculated automatically as
it changes.
DDE has largely been superseded by Object Linking and Embedding
(OLE). |
| DDL |
Device descriptor language |
| Dead code |
Routines that can never be accessed because all
calls to them have been removed, or code that cannot be reached
because it is guarded by a control structure that provably must
always transfer control somewhere else. The presence of dead code
may reveal either logical errors due to alterations in the program
or significant changes in the assumptions and environment of the
program (see also software rot); a good compiler should report dead
code so a maintainer can think about what it means. (Sometimes it
simply means that an extremely defensive programmer has inserted
can't happen tests which really can't happen -- yet.).
Ref: www.jargon.org |
| Debugging |
The activity of first determining the exact
nature and location of the suspected error within the program and
second fixing or repairing the error. |
| Declaration of conformity |
A Hewlett-Packard publication that testifies
that the equipment has been tested and found to meet shipment
release specifications. |
| Declaration of System
Validation |
A Hewlett-Packard publication that testifies
that the HPLC ChemStation has been validated during its development
and according to the Hewlett-Packard Analytical Products Group Life
Cycle. |
| DES |
Data Encryption Standard - A standard method of
encrypting and decrypting data, developed by the U.S. National
Bureau of Standards. DES works by a combination of transposition and
substitution. It is used by the federal government and most banks
and money-transfer systems to protect all sensitive computer
information.
(Ref: Dyson, Dictionary of Networking) |
| Design |
The process of defining the architecture,
components, interfaces, and other characteristics of an (automated)
system or component. |
| Design qualification (DQ) |
"Design qualification (DQ) defines the
functional and operational specifications of the instrument and
details the conscious decisions in the selection of the supplier" |
| Design review |
Planned, scheduled, and documented audit of all
pertinent aspects of the design that can affect performance, safety
or effectiveness. |
| Design specifications |
Description of the physical and functional ,
requirements for an article. In its initial form, the design
specification is a statement of functional requirements with only
General coverage of physical and test requirements. The design
specification evolves through the research and development phase to
reflect progressive refinements in performance, design,
configuration, and test requirements. |
| DHCP |
Dynamic Host Certification Protocol - A system
based on network interface card addresses that is used to allocate
IP addresses and other configuration information automatically for
networked systems. DHCP is an update of the Bootstrap Protocol.
(Ref: Dyson, Dictionary of Networking) |
| DHSS |
Department of Health and Social Security.
Former name of the British Health Authority, now Department of
Health. |
| DIA |
Drug Information Association |
| Digital signature |
Digital signature means an electronic signature
based upon cryptographic methods of originator authentication,
computed by using set of rules and a set of parameters such that the
identity of the signer and the integrity of the data can be
verified. |
| DIN |
1. Drug Information Number, an approval number
given by the Canadian Health Protection Branch.
2. Deutsches Institut für Normung, the German Standards Institute. |
| DIP switch |
A small switch used to select the operating
mode of a device, mounted as a dual in-line package. DIP switches
can be either sliding or rocker switches, and they are often grouped
for convenience. They are used in printed circuit boards, dot-matrix
printers, modems, and many other peripheral devices.
(Ref: Dyson, Dictionary of Networking) |
| Direct (data) entry |
Means recording data where an electronic record
is the original capture of the data. Examples are the keying by an
individual of original observations into the system, or automatic
recording by the system of the output of a balance that measures
subject’s body weight. |
| Disaster recovery plan |
A document that lists all activities required
to restore a system to the conditions that prevailed before the
disaster occurred, for example, after power failure. |
| DLSw |
Data Link Switching.
(Ref: Dyson, Dictionary of Networking) |
| DMF |
Drug master file |
| DMPK |
Drug Metabolism and Pharmacokinetics |
| DNS |
The domain name service (DNS) is the way that
Internet domain names are located and translated into IP addresses.
A domain name is a meaningful and usually easy-to-remember "handle"
for an Internet address.
(Ref: Dyson, Dictionary of Networking) |
| Docket |
Administrative record of the US FDA. It is a
file in wich records for a particular subject are received by the
agency and are made available to the public. |
| DOS |
Disk operating system (from Microsoft) |
| DQ |
see Design Qualification |
| DRA |
Drug Regulatory Affairs |
| Drug Information
Association |
- Library of DIA journal articles, newsletter editions
- Search engine allows users to search for articles from the
DIA Journal.
- Resource for internships in industry, grants, awards and
fellowships.
- Site includes a members only "Conference Center" which
allows members to reserve a virtual conference room and schedule
password protected chat sessions with others who have been given
the password to the conference room. A printed copy of the
conference proceedings will be mailed to the Conference Leader
upon his/her request.
- Other sites of interest - Hyperlink - USP, medical journals,
university libraries, UK health organizations
- Live video satellite conferences
- Translated technical terms available in English, French,
German, Italian and Spanish
|
| Dynamic RAM |
Abbreviated DRAM, pronounced "dee-ram." A
common type of computer memory that uses capacitors and transistors
storing electrical charges to represent memory states. These
capacitors lose their electrical charge, so they need to be
refreshed every millisecond, during which time they cannot be read
by the processor.
DRAM chips are small, simple, cheap, easy to make, and hold
approximately four times as much information as a static RAM (SRAM)
chip of similar complexity. However, they are slower than SRAM.
(Ref: Dyson, Dictionary of Networking) |
| DSG |
Digital Signature Guidelines |
| DSL |
Digital subscriber line, e-g., TDSL for Telecom |