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Glossary  C - D

C
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
Critical Process Parameter
(CPP)
Critical Process Parameter (CPP) A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality (ICH Q8)
Critical Quality Attribute (CQA) A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality (ICH Q8)
CRO Contract Research Organization
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
D
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.).
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 Space The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality. Working within the design space is not considered as a change. Movement out of the design space is considered to be a change and would normally initiate a regulatory post approval change process. Design space is proposed by the applicant and is subject to regulatory assessment and approval (ICH Q8).
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