Circular rotating magnetic storage hardware. A technique for error detection to ensure that data or program files have been accurately copied or transferred. Typical contents include system or component architecture, control logic, data structures, data flow, input/output formats, interface descriptions and algorithms. macro. (NBS) Determination of the correctness of the final program or software produced from a development project with respect to the user needs and requirements. See: abstraction. New object modules can be easily created by inheriting the characteristics of existing classes. A sequence of adjacent bits, usually eight, operated on as a unit. A structured software design technique, deriving the structure of a system from analyzing the transactions that the system is required to process. (ISO) The time interval between the instant at which a call for data is initiated and the instant at which the delivery of the data is completed. (IEEE) (1) A condition or capability needed by a user to solve a problem or achieve an objective. (IEEE) The ease with which a software system or component can be modified to correct faults, improve performance or other attributes, or adapt to a changed environment. Data structures are assessed for data dependencies that circumvent isolation, partitioning, data aliasing, and fault containment issues affecting safety, and the control or mitigation of hazards. validation, process. central processing unit. (IEEE) A software development technique that consists of isolating a system function or a set of data and the operations on those data within a module and providing precise specifications for the module. Another main concern is also to reduce tobacco consumption by minors, i.e., people under the minimum smoking age. (2) A set of definitions of data flows, data elements, files, data bases, and processes referred to in a leveled data flow diagram set. An asynchronous file transfer protocol that is more efficient than Xmodem. editing. Syn: dead code. See: debugging, failure analysis. perfective maintenance. (IEEE) (1) A separately testable element specified in the design of a computer software element. (IEEE) A data flow, data structure, or other diagram in which entities are depicted with circles [bubbles] and relationships are represented by links drawn between the circles. (IEEE) A storage allocation technique in which programs or data are divided into fixed length blocks called pages, main storage/memory is divided into blocks of the same length called page frames, and pages are stored in page frames, not necessarily contiguously or in logical order, and pages are transferred between main and auxiliary storage as needed. graph. The terms are defined, as much as possible, using available standards. design review. See: dynamic analysis, static analysis, software engineering. defect. white-box testing. 100-1992. Hardware used to read from or write to a disk or diskette. extended ASCII. This means this IC does not necessarily have to be removed from the circuit in which it is mounted in order to erase and reprogram the memory. control bus. proof of correctness. (Myers/NBS) A manual testing [error detection] technique where program [source code] logic [structure] is traced manually [mentally] by a group with a small set of test cases, while the state of program variables is manually monitored, to analyze the programmer's logic and assumptions. logic analysis. (3) The elementary unit of a record that may contain a data item, a data aggregate, a pointer, or a link. medium scale integration. (IEEE) A language used to identify a sequence of jobs, describe their requirements to an operating system, and control their execution. preliminary design. data validation. system administrator. Drugs@FDA Glossary. (NBS) The use of techniques of mathematical logic to infer that a relation between program variables assumed true at program entry implies that another relation between program variables holds at program exit. The New IEEE Standard Dictionary of Electrical and Electronics Terms, IEEE Std. However, one baud can be made to represent more than one bit per second. (2) A linear sequence of entities such as characters or physical elements. server. quality assurance. underflow. code walkthrough. Written procedures describing coding [programming] style conventions specifying rules governing the use of individual constructs provided by the programming language, and naming, formatting, and documentation requirements which prevent programming errors, control complexity and promote understandability of the source code. software development process. An asynchronous file transfer protocol identical to Xmodem-1K plus batch file transfer [also called Ymodem batch]. Contrast with check summation, cyclic redundancy check [CRC]. Pertaining to the principles of mathematical logic developed by George Boole, a nineteenth century mathematician. interpret. The TELENET protocol provides a terminal emulation capability that allows a user to interact with any other type of computer in the network. flag. Syn: call trace. See: servomechanism. file maintenance. See: verification, software. (2) A named identifier of each of the entities and their attributes that are represented in a database. An MSI IC contains 100 to 3,000 transistors. The bus is often divided into two channels, a control channel to select where data is located [address bus], and the other to transfer the data [data bus or I/O bus]. International Telecommunications Union - Telecommunications Standards Section. (2) The degree to which a requirement is stated in terms that permit establishment of test criteria and performance of tests to determine whether those criteria have been met. cause effect graphing. See: International Telecommunications Union - Telecommunications Standards Section. rapid prototyping. (DOD) The application of engineering and management principles, criteria, and techniques to optimize all aspects of safety within the constraints of operational effectiveness, time, and cost throughout all phases of the system life cycle. An incorrect step, process, or data definition in a computer program which causes the program to perform in an unintended or unanticipated manner. touch sensitive. It will facilitate consistency in describing the requirements of the law and regulations applicable to such products and systems. A technology for writing programs that are made up of self-sufficient modules that contain all of the information needed to manipulate a given data structure. (IEEE) A specification language with special constructs and, sometimes, verification protocols, used to develop, analyze, and document a program design. See: release. (IEEE) Analysis of a computer program [source code] to identify all possible paths through the program, to detect incomplete paths, or to discover portions of the program that are not on any path. See: kilobyte, megabyte. See: disk, disk drive. (2) The result of the process in (1). VV&T. Beizer, B., Software Testing Techniques, Second Edition, Van Nostrand Reinhold, 1990. Program code statements which can never execute during program operation. serial. Note: It is said that a null string has length zero. Syn: parallel run. Syn: object code. A distinction can be made between a warm boot and a cold boot. (IEEE) A user-defined unit of work that is to be accomplished by a computer. The approval history is a chronological list of all FDA actions involving one drug product having a particular FDA Application number (NDA). hard disk drive. (IEEE) Analysis to ensure that all portions of the program follow approved programming guidelines. See: assertion checking, instrumentation. See: design phase, architectural design, functional design. version number. Syn: digraph. See: waterfall model. UNIX. (IEEE) The tracing of (1) Software Requirements Specifications requirements to system requirements in concept documentation, (2) software design descriptions to software requirements specifications and software requirements specifications to software design descriptions, (3) source code to corresponding design specifications and design specifications to source code. as built. comment. (IEEE) A mode of operation that permits two or more users to execute computer programs concurrently on the same computer system by interleaving the execution of their programs. (ISO) In an arithmetic operation, a result whose absolute value is too small to be represented within the range of the numeration system in use. spiral model. Identifies Digital Equipment Corporation's VAX family of computers, ranging from a desktop workstation to a large scale cluster of multiprocessors supporting thousands of simultaneous users. A measure of reliability of a piece of repairable equipment, giving the average time between repairs. (NIST) A collection of material pertinent to the development of a software module. (IEEE) A process or meeting during which a system, hardware, or software design is presented to project personnel, managers, users, customers, or other interested parties for comment or approval. This document is intended to serve as a glossary of terminology applicable to software development and computerized systems in FDA regulated industries. auxiliary storage. (IEEE) A document that specifies, in a complete, precise, verifiable manner, the requirements, design, behavior,or other characteristics of a system or component, and often, the procedures for determining whether these provisions have been satisfied. Contrast with batch. Communications systems that use optical fibers for transmission. Transmissions [communications] which occur in only one direction at a time, but that direction can change. (ANSI) A bus carrying the signals that regulate system operations. software documentation. (NBS) A selection technique in which test data are chosen to lie along "boundaries" of the input domain [or output range] classes, data structures, procedure parameters, etc. See: cross-assembler, cross-compiler. Contrast with testing, path; testing, statement. See: code audit, code inspection. (DOD) An assessment of the consequence of the worst credible mishap that could be caused by a specific hazard. It sends file name, date and size first, and responds well to changing line conditions due to its variable length blocks. A device or storage area [memory] used to store data temporarily to compensate for differences in rates of data flow, time of occurrence of events, or amounts of data that can be handled by the devices or processes involved in the transfer or use of the data. Contrast with demodulation. industry standard. See: firmware. instruction set. McGraw-Hill Electronics Dictionary, Fifth Edition, 1994, McGraw-Hill Inc. McGraw-Hill Dictionary of Scientific & Technical Terms, Fifth Edition, 1994, McGraw-Hill Inc.. Webster's New Universal Unabridged Dictionary, Deluxe Second Edition, 1979. testing, path. Hardware that controls peripheral devices such as a disk or display screen. This is accomplished through I/0 ports and devices. hierarchy of input-processing-output chart. failure. Such a firm could be a medical device manufacturer. fault. (IEEE) (1) Evaluation of the description and intended use of each data item in the software design to ensure the structure and intended use will not result in a hazard. As ADD, SUBTRACT, MULTIPLY, and DIVIDE are the primary operations of arithmetic, AND, OR, and NOT are the primary operations of Boolean Logic. hierarchy of input-processing-output. (Myers/NBS) A manual [formal] testing [error detection] technique where the programmer reads source code, statement by statement, to a group who ask questions analyzing the program logic, analyzing the code with respect to a checklist of historically common programming errors, and analyzing its compliance with coding standards. A device, usually equipped with a CRT display and keyboard, used to send and receive information to and from a computer via a communication channel. A manual testing technique in which program documents [specifications (requirements, design), source code or user's manuals] are examined in a very formal and disciplined manner to discover errors, violations of standards and other problems. operating system. See: storage device. A structured software requirements discovery technique which emphasizes generating prototypes early in the development process to permit early feedback and analysis in support of the development process. constant. A standard method of interfacing a computer to disk drives, tape drives and other peripheral devices that require high-speed data transfer. A facet of reliability that relates to the degree of certainty that a system or component will operate correctly. access time. (ISO) A violation of data integrity. (IEEE) A constant, variable or expression that is used to pass values between software modules. Selection of the level may be based on project cost, intended usage, extent of effort, or other factors; e.g., level of concern. (ANSI/IEEE) A software tool that aides in the evaluation of a computer program without executing the program. stub. The data are stored so that they can be used by different programs without concern for the data structure or organization. The File Transfer Protocol and Simple Mail Transfer Protocol provide file transfer and electronic mail capability. (IEEE) A model of the software development process in which the constituent activities, typically requirements analysis, preliminary and detailed design, coding, integration, and testing, are performed iteratively until the software is complete. protocol. black-box testing. finger, contact. (3) A peripheral device which permits two or more devices to communicate. basic input/output system. See: testing, boundary value; testing, invalid case; testing, special case; testing, stress; testing, volume. (IEEE) (1) The degree to which a system or component facilitates the establishment of test criteria and the performance of tests to determine whether those criteria have been met. (IEEE) (1) A planned and systematic pattern of all actions necessary to provide adequate confidence that an item or product conforms to established technical requirements. Acronyms are expanded at the beginning of each alphabetical section and defined with the full term or phrase. A method for handling constantly changing data. (1) (ANSI/IEEE) A program statement that causes a computer to perform a particular operation or set of operations. (IEEE) Testing conducted to determine whether or not a system satisfies its acceptance criteria and to enable the customer to determine whether or not to accept the system. It may be in one of two states, logic 1 or logic 0. See: structured design, design description, specification. (NIST) A formal document developed from a test plan that presents detailed instructions for the setup, operation, and evaluation of the results for each defined test. The modules are created in class hierarchies so that the code or methods of a class can be passed to other modules. The interpreter must be resident in the computer each time a program [source code file] written in an interpreted language is executed. An OCR peripheral device accepts a printed document as input, to identify the characters by their shape from the light that is reflected and creates an output disk file. See: configuration control, change control, software engineering. An automated system for the support of software development including an integrated tool set, i.e., programs, which facilitate the accomplishment of software engineering methods and tasks such as project planning and estimation, system and software requirements analysis, design of data structure, program architecture and algorithm procedure, coding, testing and maintenance. (1) (ISO) In programming languages, a language construct that allows [explanatory] text to be inserted into a program and that does not have any effect on the execution of the program. analog device. An output device. It is expressed in cycles per second [Hz], and also is often stated in bits or bytes per second. It holds the programs and data that are shared by all users. NIST. embedded software. (ANSI) (1) A person, device, program, or computer system that uses an information system for the purpose of data processing in information exchange. Institute of Electrical and Electronic Engineers. failure analysis. system design. (1) Sound. decision table. Syn: code trace, control flow trace. February 2, 2016; FDA News; On January 28, 2016, an FDA and NIH Joint Leadership Council published its first official glossary of terms and definitions, which “clarifies important definitions and describes some of the hierarchical relationships, connections, and dependencies among the terms it contains.”. cathode ray tube. (2) Term describing the transmission of data one bit at a time. feasibility studies, system definition documentation, regulations, procedures, or policies relevant to the project. (NIST) Used as an entity to define a procedure of review, analysis, and testing throughout the software life cycle to discover errors, determine functionality, and ensure the production of quality software. A programmable logic chip. data structure centered design. See: source program, programming language. Precisely 1024 K Bytes, 220 bytes, or 1,048,576 bytes. compatibility. Using a modem to communicate between computers. See: structured design. (IEEE) A discipline applying technical and administrative direction and surveillance to identify and document the functional and physical characteristics of a configuration item, control changes to those characteristics, record and report change processing and implementation status, and verifying compliance with specified requirements. analog-to-digital converter. The process of translating a design into hardware components, software components, or both. For example, if the calculator output capacity is four digits, the number .0000432 will be shown as .0000. testing, exhaustive. See: microprocessor. Pertaining to data [signals] in the form of discrete [separate/pulse form] integral values. corrective maintenance. kilobyte. See: incremental development, rapid prototyping, spiral model, waterfall model. Syn: accident. A table which lists events and the corresponding specified effect[s] of or reaction[s] to each event. criticality. A symbol chosen to assist human memory and understanding; e.g., an abbreviation such as "MPY" for multiply. Syn: link editor, linker. object program. (2) The transforming of logic and data from design specifications (design descriptions) into a programming language. 321-394)). Glossary. A method of electrical transfer in which a constant time interval is maintained between successive bits or characters. See: testing, compatibility. (CDRH) (3) The measure of an instrument's capability to approach a true or absolute value. This method is useful if the device's data can wait for a period of time before being processed, since each device must await its turn in the polling scheme before it will be serviced by the processor. See: band. ROM memory is also random access memory, but they are read only not read/write memories. This analysis is to show this isolation is complete and that interfaces between safety-critical code and non-safety-critical code do not create hazards. See: static analysis. modem access. (IEEE) A chronological record of all relevant details about the execution of a test. Contrast with analog. interrupt analyzer. The two types of memory are main; e.g., ROM, RAM, and auxiliary; e.g., tape, disk. completeness. (NIST) A code expressed in machine language ["1"s and "0"s] which is normally an output of a given translation process that is ready to be executed by a computer. worm. data integrity. A term used to describe a small computer. FORTRAN. Contrast with LAN, MAN. (1) Pertaining to the sequential processing of the individual parts of a whole, such as the bits of a character or the characters of a word, using the same facilities for successive parts. Syn: test data generator, test generator. See: coding. (IEEE) The degree to which a collection of data is complete, consistent, and accurate. Performed when more than one software system is being integrated. Dead code can be confusing, and is a potential source of erroneous software changes. See: computer language, high-level language, low-level language. A trojan horse which attacks a computer system upon the occurrence of a specific logical event [logic bomb], the occurrence of a specific time-related logical event [time bomb], or is hidden in electronic mail or data and is triggered when read in a certain way [letter bomb]. parallel. structured query language. extremal test data. (IEEE) The process of testing an integrated hardware and software system to verify that the system meets its specified requirements. (Myers) A test case identification technique which produces enough test cases such that each decision has a true and a false outcome at least once. An organization involved in the generation and promulgation of standards. It's the switching speed, or number of transitions [voltage or frequency change] made per second. (NIST) A description of required documentation indicating its scope, content, format, and quality. extended binary coded decimal interchange code. EU IVDR. See: routine, subprogram. (1) To separate into elemental parts or basic principles so as to determine the nature of the whole. (ODE, CDRH) The identification of safety-critical software, the classification and estimation of potential hazards, and identification of program path analysis to identify hazardous combinations of internal and environmental program conditions. Contrast with code audit, code inspection, code walkthrough. string. (IEEE) A compiler that executes on one computer but generates assembly code or object code for a different computer. implementation. (NBS) Test data that is at the extreme or boundary of the domain of an input variable or which produces results at the boundary of an output domain. hierarchical decomposition. Contrast with modulation. The other system is considered as the standard of comparison. For time critical operations, assembly language may be necessary in order to generate code which executes fast enough for the required operations. During testing the computational hardware, the external environment, and even code segments may be simulated. crash. See: boundary value analysis; testing, stress. overflow exception. non-maskable interrupt. interface requirement. A warm boot means restarting the computer while it is powered-up. (IEEE) Documentation specifying the scope, approach, resources, and schedule of intended testing activities. (NIST) Translating a program expressed in an assembly language into object code. For NIST publications, an email is usually found within the document. (IEEE) A static analysis technique in which program execution is simulated using symbols, such as variable names, rather than actual values for input data, and program outputs are expressed as logical or mathematical expressions involving these symbols. A refinement called hierarchical input-process-output identifies the steps, inputs, and outputs at both general and detailed levels of detail. CAD software may also be highly specialized for creating products such as printed circuits and integrated circuits. The base 8 number system. An asynchronous file transfer protocol initially developed for CP/M personal computers. Approximately one million bits. quality assurance, software. FDA Guide to Inspection of Computerized Systems in Drug Processing, 1983. Contrast with dynamic analysis. A special type of event table. A classification of ICs [chips] based on their size as expressed by the number of circuits or logic gates they contain. assembly language. specification. concept phase. Ethernet is a common LAN architecture using a bus topology. development standards. (2) (IEEE) The process of evaluating a system or component based on its form, structure, content, documentation. A chip which may be programmed by using a PROM programming device. testing, worst case. See: test procedure. Data is transmitted and received in serial format. See: bug, crash, exception, fault. The advantage of assembly language is that it provides bit-level control of the processor allowing tuning of the program for optimal speed and performance. See: failure analysis. transaction analysis. cyclomatic complexity. An exact or detailed plan or outline. bias. a terminal or a computer. assembling. A device which takes information from any of several sources and places it on a single line or sends it to a single destination. test incident report. See: data structure centered design, input-processing-output, modular decomposition, object oriented design, rapid prototyping, stepwise refinement, structured programming, transaction analysis, transform analysis, graphical software specification/design documents, modular software, software engineering. (NBS) Special code segments that when invoked by a code segment under test will simulate the behavior of designed and specified modules not yet constructed. platform. verify. See: software engineering. (NIST) A management document describing the approach to a documentation effort. Note: This term is defined differently in various programming languages. CP/M. test documentation. criticality analysis. See: job control language. (IEEE) Maintenance performed to correct faults in hardware or software. A classification of ICs [chips] based on their size as expressed by the number of circuits or logic gates they contain. The separation of the logical properties of data or function from its implementation in a computer program. (2) The ability of a program to perform its required functions accurately and reproducibly under stated conditions for a specified period of time. error seeding. Contrast with incremental development; rapid prototyping; spiral model. It implies software that integrates operating system and application functions. mishap. Contrast with requirement. A non-moving storage device utilizing one of a number of types of electronic circuitry to store information. A seven bit code adopted as a standard to represent specific data characters in computer systems, and to facilitate interchange of data between various machines and systems. (ISO) That portion of a numeric word that expresses the result of an arithmetic operation, by which the length of the word exceeds the word length of the space provided for the representation of the number. This document is intended to serve as a glossary of terminology applicable to software development and computerized systems in FDA regulated industries. (FDA) Establishing confidence that process equipment and ancillary systems are compliant with appropriate codes and approved design intentions, and that manufacturer's recommendations are suitably considered. complex instruction set computer. Linear magnetic storage hardware, rolled onto a reel or cassette. error analysis. metric based test data generation. FDA-NIH BEST Biomarker Glossary Now Available Precise, clear communication across all scientific research disciplines is crucial for more efficient translational of laboratory discoveries into new treatments for patients. Whereas, software under minor level of concern requires seven different documents. utility software. Contrast with nonincremental integration. A standard interface for hard disks introduced in 1983 which provides for faster data transfer compared to ST-506. debugging. A structured software design technique in which system structure is derived from analyzing the flow of data through the system and the transformations that must be performed on the data. Contrast with requirement. sparks, from a non-conductive surface to an approaching conductive object that can damage or destroy semiconductors and other circuit components. An international organization for communications standards. data bus. International Electrotechnical Commission. (NIST) A diagram of a system, instrument or computer, in which the principal parts are represented by suitably annotated geometrical figures to show both the basic functions of the parts and the functional relationships between them. (1) (ANSI) People, machines, and methods organized to accomplish a set of specific functions. (IEEE) A record of the name and values of variables accessed or changed during the execution of a computer program. embedded computer. (IEEE) A requirement that specifies an external item with which a system or system component must interact, or sets forth constraints on formats, timing, or other factors caused by such an interaction. (2) (NBS) The cyclomatic complexity of a program is equivalent to the number of decision statements plus 1. data. Analyze identified relationships for correctness, consistency, completeness, and accuracy. (IEEE) Testing conducted to evaluate whether systems or components pass data and control correctly to one another. Small wafers of semiconductor material [silicon] etched or printed with extremely small electronic switching circuits. Contrast with synchronous transmission. See: validation, software. Myers, G., The Art of Software Testing, Wiley Interscience, 1979. 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