(IEEE) Standards that describe the characteristics of a design or a design description of data or program components. Contrast with EDSI, IDE, SCSI. This value is a representation of the set of no numbers or no value for the operating system in use. (IEEE) The protection of computer hardware and software from accidental or malicious access, use, modification, destruction, or disclosure. hazard severity. tape. (IEEE) (1) In software engineering, the process of expressing a computer program in a programming language. Execution speed of a computer. (ANSI) (1) To determine whether a transcription of data or other operation has been accomplished accurately. The transmission capacity of a computer channel, communications line or bus. personal computer. relational database. verifiable. (4) In programming languages, a subdivision of a program that serves to group related statements, delimit routines, specify storage allocation, delineate the applicability of labels, or segment parts of the program for other purposes. and operate a system from its conception to the termination of its use. GLOSSARY PAGES IN DEPTH ... FDA Warning Letters. assertion. bias. call graph. Any device or recording medium into which binary data can be stored and held, and from which the entire original data can be retrieved. (IEEE) A variable that is set to a prescribed state, often "true" or "false", based on the results of a process or the occurrence of a specified condition. design level. workaround. software documentation. See: coroutine, main program, routine, subroutine. See: structured design. (ISO) A discrepancy between a computed, observed, or measured value or condition and the true, specified, or theoretically correct value or condition. See: software reliability. See: test case. Contrast with mutation analysis. (1) (ISO) A sequence of instructions suitable for processing. A relational database programming system incorporating the SQL programming language. See: compiler. Comments about specific definitions should be sent to the authors of the linked Source publication. A type of microelectronic circuit used for logic and memory chips. compilation. testing, storage. Syn: hierarchy chart, program structure chart. Syn: machine instruction set. safety critical. (2) Software requirements and design specifications. Often taken as the simple product of probability and consequence. as built. (IEEE) Maintenance performed to correct faults in hardware or software. design requirement. An MSI IC contains 100 to 3,000 transistors. The advantage of ROM over RAM is that ROM does not require power to retain its program. branch analysis. (1) (IEEE) A computer program that translates programs expressed in a high-level language into their machine language equivalents. Gaithersburg, MD 20899. See: radiofrequency interference. (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. default value. (1) (ISO) A mathematical entity whose value, namely, the value of the dependent variable, depends in a specified manner on the values of one or more independent variables, with not more than one value of the dependent variable corresponding to each permissible combination of values from the respective ranges of the independent variables. Syn: system manager. Firmware that activates peripheral devices in a PC. (2) (ISO) To design, write, and test programs. Typically one to four bytes long, depending on the make of computer. A band can be identified by the difference between its lower and upper limits, i.e. EPROMs may be erased and reprogrammed because the electrical charge at the bit locations can be bled off [i.e. (NIST) A management document describing the approach taken for a project. version. Output related devices which translate a computer's digital outputs to the corresponding analog signals needed by an output device such as an actuator. (IEEE) (1) The process of refining and expanding the preliminary design of a system or component to the extent that the design is sufficiently complete to be implemented. Page 2 Guidance for Industry and FDA Staff General Principles of Software Validation In that case, the party with regulatory responsibility (i.e., the device manufacturer) needs to assess the (NIST) Translating a program expressed in an assembly language into object code. twisted pair. boundary value analysis. See: programmable logic device. Contrast with multi-programming. transform analysis. (IEC) A method of reliability analysis intended to identify failures, at the basic component level, which have significant consequences affecting the system performance in the application considered. (NIST) Translating a program expressed in a problem-oriented language or a procedure oriented language into object code. Contrast with constant. (Myers) Determining the exact nature and location of a program error, and fixing the error. archive. Digital Equipment Corporation's multiprocessing, interactive operating system for the VAX computers. An object-oriented high-level programming language. specification, system. object oriented design. the process involves translating user needs into software requirements, transforming the software requirements into design, implementing the design in code, testing the code, and sometimes installing and checking out the software for operational activities. There are several varieties of MOS technologies including PMOS, NMOS, CMOS. (IEEE) A requirement that specifies or constrains the coding or construction of a system or system component. (4) Loosely, a routine. macro. (ANSI) To obtain the use of a resource. audit. (IEEE) A requirement that specifies or constrains the design of a system or system component. Contrast with testing, branch; testing, path; branch coverage; condition coverage; decision coverage; multiple condition coverage; path coverage. (2) The ability of a program to perform its required functions accurately and reproducibly under stated conditions for a specified period of time. code auditor. Contrast with condition coverage, multiple condition coverage, path coverage, statement coverage. (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. (2) A specific purpose of an entity, or its characteristic action. Such testing may be conducted in both the development environment and the target environment. (1) In programming languages, a self- contained subdivision of a program that may be separately compiled. end user. integrated circuit. (1) Sound. (IEEE) A quantitative assessment of the degree to which a software product or process possesses a given attribute. (IEEE) Documentation specifying the scope, approach, resources, and schedule of intended testing activities. Acronyms are expanded at the beginning of each alphabetical section and defined with the full term or phrase. This document is intended to serve as a glossary of terminology applicable to software development and computerized systems in FDA regulated industries. overflow exception. One path from each class is then tested. See: validation, software. See: configuration control, change control, software engineering. Contrast with demodulate. A measure of the speed of data transfer in a communications system. data analysis. specification, design. (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. See: architectural design. design standards. (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. (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. (IEEE) The period of time in the software life cycle during which the requirements, such as functional and performance capabilities for a software product, are defined and documented. (IEEE) A diagram that depicts the set of all possible sequences in which operations may be performed during the execution of a system or program. Syn: twisted wire pair. Unlike electrical pulses, light pulses are not affected by random radiation in the environment. A registered trademark of Digital Research. (IEEE) A language used to identify a sequence of jobs, describe their requirements to an operating system, and control their execution. Contrast with requirement. Examples include checkers, compilers, cross-reference generators, standards enforcers, and flowcharters. data set. (IEEE) Verification that the safety-critical portion of the software design correctly implements the safety-critical requirements and introduces no new hazards. time sharing. Contrast with incremental development; rapid prototyping; spiral model. (3) A documented representation of a condition or capability as in (1) or (2). A warm boot means restarting the computer while it is powered-up. transmission control protocol/Internet protocol. multi-tasking. validation protocol. Pertaining to data [signals] in the form of discrete [separate/pulse form] integral values. This term is derived from the term "picture element". See: source program, programming language. COTS. (IEEE) Software designed to fill specific needs of a user; for example, software for navigation, payroll, or process control. Syn: optical disk, write-once read-many times disk. documentation plan. A standard interface for hard disks which provides for building most of the controller circuitry into the disk drive to save space. An information processing technology that converts human readable data into another medium for computer input. See: requirements phase. archive file. Written procedures [prescribing and describing the steps to be taken in normal and defined conditions] which are necessary to assure control of production and processes. See: programming language. corrective maintenance. (NBS) Test data selection technique. Such software cannot be modified by the computer during processing. Contrast with assemble, compile. Techniques used to identify errors in data transfers. Syn: argument. test phase. A testing technique using input values that seem likely to cause program errors; e.g., "0", "1", NULL, empty string. CAD output is a printed design or electronic output to CAM systems. field. electrically erasable programmable read only memory. A software tool used to test output data reduction, formatting, and printing. (IEEE) Computer instructions and definitions expressed in a form [binary code] that can be recognized by the CPU of a computer. (Myers) A test coverage criteria requiring enough test cases such that each condition in a decision takes on all possible outcomes at least once, and each point of entry to a program or subroutine is invoked at least once. kilobyte. Note: The result is not necessarily the same as that shown in a call graph. See: cross-assembler, cross-compiler. (IEEE) A diagram of a software system or module, consisting of a rectangle on the left listing inputs, a rectangle in the center listing processing steps, a rectangle on the right listing outputs, and arrows connecting inputs to processing steps and processing steps to outputs. Syn: component, module. Ymodem-G transmits without acknowledgement [for error-free channels or when modems are self correcting], but transmission is cancelled upon any error. Completeness of a product is often used to express the fact that all requirements have been met by the product. compatibility. See: configuration control. Four modifications are the grouping of terms and phrases in the domains of specifications, testing, qualification, and validation. A table which lists events and the corresponding specified effect[s] of or reaction[s] to each event. completeness. interface analysis. See: utility software. This technique is often called stress testing. software safety change analysis. (IEEE) A computer program that translates programs [source code files] written in assembly language into their machine language equivalents [object code files]. specification, programming. The concept involves the specification of the connection of two devices having different functions. Approximately one million bytes. Acronym for COmmon Business Oriented Language. The hardware and software which must be present and functioning for an application program to run [perform] as intended. telecommunication system. (3) Term describing simultaneous transmission of the bits making up a character, usually eight bits [one byte]. Contrast with DAC [digital-to-analog converter]. Communications network that covers a geographical area such as a city or a suburb. They perform general functions such as formatting electronic media, making copies of files, or deleting files. extended ASCII. (NBS) Analysis that is performed by executing the program code. (FDA) Establishing confidence through appropriate testing that the finished product produced by a specified process meets all release requirements for functionality and safety. Disks can be hard [fixed] or flexible [removable] and different sizes. (2) The process of studying and refining system, hardware, or software requirements. (3) In a database management system, a unit of processing activity that accomplishes a specific purpose such as a retrieval, an update, a modification, or a deletion of one or more data elements of a storage structure. small scale integration. (IEEE) A deliverable or in- process document produced or acquired during software development or maintenance. See: equivalence class partitioning. programming language. (2) Evaluation of the data structure and usage in the code to ensure each is defined and used properly by the program. (2) Evaluates the sequence of operations represented by the coded program and detects programming errors that might create hazards. A value assigned automatically if one is not given by the user. programmable array logic. Contrast with asynchronous transmission. Digital data is represented very compactly by tiny holes that can be read by lasers attached to high resolution sensors. Contrast with design standards, requirement. (NBS) Test data that lie within the domain of the function represented by the program. Syn: software audit. test case generator. n-channel MOS. parallel processing. Contrast with Kermit, Xmodem, Zmodem. transaction flowgraph. A multitasking, multiple-user (time-sharing) operating system developed at Bell Labs to create a favorable environment for programming research and development. computer aided software engineering. It may be thought of as a switch which is either on or off. (1) (NBS) Test data that lie outside the domain of the function the program represents. virus. See: kilobyte, megabyte, gigabyte. inspection. (1) (NIST) Testing of a module for typographic, syntactic, and logical errors, for correct implementation of its design, and for satisfaction of its requirements. Digits are 0, 1, 2, 3, 4, 5, 6, & 7. on-line. Electronic equipment which is used to transfer a program [write instructions and data] into PROM and EPROM chips. assembler. (IEEE) A diagram or other representation consisting of a finite set of nodes and internode connections called edges or arcs. structured query language. (2) The human readable version of the list of instructions [program] that cause a computer to perform a task. Test data is useful only if the methods and results are adequately specific. Contrast with serial. International Electrotechnical Commission, International Standard 1025, Fault Tree Analysis. software development plan. modulation. See: overflow, overflow exception. This and other terminology used by the FDA are updated and made available for download via the NCI File Transfer Protocol (FTP). risk. (DOD) An unplanned event or series of events resulting in death, injury, occupational illness, or damage to or loss of data and equipment or property, or damage to the environment. (IEEE) A requirement that imposes conditions on a functional requirement; e.g., a requirement that specifies the speed, accuracy, or memory usage with which a given function must be performed. Contrast with data flow diagram. (IEEE) A record of the sequence of instructions executed during the execution of a computer program. (Myers) Partitioning the input domain of a program into a finite number of classes [sets], to identify a minimal set of well selected test cases to represent these classes. (IEEE) (1) A condition or mode of existence that a system, component, or simulation may be in; e.g., the pre-flight state of an aircraft navigation program or the input state of a given channel. (IEEE) Pertaining to a system or mode of operation in which input data enter the computer directly from the point of origin or output data are transmitted directly to the point where they are used. 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