real time. See: bomb, trojan horse, virus, worm. Normally there are two associated with a computer system, hardware and software. Types include addressing exception, data exception, operation exception, overflow exception, protection exception, underflow exception. Contrast with testing, acceptance; testing, operational. (IEEE) A quantitative measure of the degree to which software possesses a given attribute which affects its quality. software life cycle. (FDA) Establishing confidence that process equipment and sub-systems are capable of consistently operating within established limits and tolerances. installation qualification. testing. design standards. synchronous. parallel processing. Syn: data-flow trace, data trace, value trace. feasibility study. concept phase. It describes what the system or component is to do rather than how it is to be built. A timing independent method of electrical transfer of data in which the sending and receiving units are synchronized on each character, or small block of characters, usually by the use of start and stop signals. Feasible only for small, simple programs. The U.S. Food and Drug Administration (FDA) is working with Enterprise Vocabulary Services (EVS) to develop and support controlled terminology in several areas. test case generator. change tracker. Note: This term is defined differently in various programming languages. null data. emulation. computerized system. The CRC is the result of a calculation on the set of transmitted bits by the transmitter which is appended to the data. (NIST) A logical expression specifying a program state that must exist or a set of conditions that program variables must satisfy at a particular point during program execution. See: computer, computer system. (2) Software requirements and design specifications. HHS Publication FDA 90-4236, Preproduction Quality Assurance Planning. (IEEE) A document which describes the as built version of the software. The software tool indicates the numbers and distribution of food and agriculture sector employees who work at FDA-regulated facilities. It derives its name from its use of metal, oxide and semiconductor layers. transaction matrix. (IEEE) A lasting collection of computer system data or other records that are in long term storage. FIPS. Contrast with rapid prototyping, spiral model, waterfall model. (2) A chronological record of system activities that is sufficient to enable the reconstruction, reviews, and examination of the sequence of environments and activities surrounding or leading to each event in the path of a transaction from its inception to output of final results. (IEEE) An n-dimensional ordered set of data items identified by a single name and one or more indices, so that each element of the set is individually addressable; e.g., a matrix, table, or vector. version number. FDA Software Guidances and the IEC 62304 Software Standard Nov 20, 2019 – FDA SW Guidances have a much broader scope, including system validation and development of non-product software. configuration. checksum. (IEEE) Software that aids in the development and maintenance of other software; e.g., compilers, loaders, and other utilities. (IEEE) Analysis to ensure that all portions of the program follow approved programming guidelines. random access memory. Those related terms are located sequentially to assist the user in finding all defined terms in these domains, e.g., functional testing is defined under testing, functional. virtual address extension. software safety requirements analysis. Whenever test data are used to demonstrate conformance to specifications, it is important that the test methodology be qualified to assure that the test results are objective and accurate. Capable of storing up to 680 MB of data, equivalent to 250,000 pages of text, or 20,000 medium resolution images. Syn: coding standards. Syn: separator. 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]. American Standard Code for Information Interchange. Test data is useful only if the methods and results are adequately specific. It may be in one of two states, logic 1 or logic 0. hexadecimal. (IEEE) A diagram that depicts data sources, data sinks, data storage, and processes performed on data as nodes, and logical flow of data as links between the nodes. (IEEE) (1) the probability that software will not cause the failure of a system for a specified time under specified conditions. simulator. (IEEE) A representation of software created to facilitate analysis, planning, implementation, and decision making. (IEEE) The period of time in the software life cycle during which the designs for architecture, software components, interfaces, and data are created, documented, and verified to satisfy requirements. (IEEE) The organizational structure of a system or component. Examples are PL/1, COBOL, BASIC, FORTRAN, Ada, Pascal, and "C". compilation. The degree to which software, documentation and other items meet specified requirements. See: regression analysis and testing. small computer systems interface. (NBS) Analysis that is performed by executing the program code. hazard probability. symbolic trace. See: traceability analysis. (IEEE) A system of error control based on the formation of a block check following preset rules. evolutionary development. Acronyms are grouped at the beginning of each alphabetical section, and are followed by words, terms and phrases. system documentation. computer. (2) Term describing the transmission of data one bit at a time. See: testing, mutation. (ANSI) In computer systems, a technical evaluation, made as part of and in support of the accreditation process, that establishes the extent to which a particular computer system or network design and implementation meet a prespecified set of requirements. See: validation, software. See: specification; specification, requirements; specification, design; software design description; test plan, test report, user's guide. A structured reformation of the program module by module or function by function with an integration test being performed following each addition. instruction. embedded computer. precision. A program which copies other [object] programs from auxiliary [external] memory to main [internal] memory prior to its execution. As ADD, SUBTRACT, MULTIPLY, and DIVIDE are the primary operations of arithmetic, AND, OR, and NOT are the primary operations of Boolean Logic. (IEEE) A string containing no entries. (NBS) The insertion of additional code into a program in order to collect information about program behavior during program execution. Syn: grouping factor. (IEEE) Evaluates the safety-critical equations, algorithms, and control logic of the software design. bias. (2) A review as in (1) for any hardware or software component. (Myers) Determining the exact nature and location of a program error, and fixing the error. (IEEE) A review conducted to evaluate the progress, technical adequacy, and risk resolution of the selected design approach for one or more configuration items; to determine each design's compatibility with the requirements for the configuration item; to evaluate the degree of definition and assess the technical risk associated with the selected manufacturing methods and processes; to establish the existence and compatibility of the physical and functional interfaces among the configuration items and other items of equipment, facilities, software and personnel; and, as applicable, to evaluate the preliminary operational and support documents. debugging. (NIST) A specification that documents the interface requirements for a system or system component. A multitasking, multiple-user (time-sharing) operating system developed at Bell Labs to create a favorable environment for programming research and development. See: configuration control, change control, software engineering. specification, system. (ISO) A character string that enables a user to have full or limited access to a system or to a set of data. testing, usability. firmware. A type of microelectronic circuit used for logic and memory chips. archive file. See: documentation plan, software development plan, test plan, software engineering. See: incremental integration. Several versions exist. Installation includes installing a new computer system, new software or hardware, or otherwise modifying the current system. functional requirement. (IEEE) Analysis of the safety-critical design elements affected directly or indirectly by the change to show the change does not create a new hazard, does not impact on a previously resolved hazard, does not make a currently existing hazard more severe, and does not adversely affect any safety-critical software design element. They may include manual procedures used in conjunction with the computer system. (ANSI) A named component of a data element. (3) A peripheral device which permits two or more devices to communicate. (NIST) A specification or product that has been formally reviewed and agreed upon, that serves as the basis for further development, and that can be changed only through formal change control procedures. 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. (IEEE) A computer program that has been purposely altered from the intended version to evaluate the ability of program test cases to detect the alteration. control flow diagram. Using software tools to accelerate the software development process by facilitating the identification of required functionality during analysis and design phases. hierarchical decomposition. (IEEE) Analysis of the safety implications of safety-critical requirements that relate to execution time, clock time, and memory allocation. The CPU controls the entire computer. (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. Performed when more than one software system is being integrated. design requirement. See: analog, digital. Program source code written without a coherent structure. (IEEE) (1) In software engineering, the process of expressing a computer program in a programming language. See: architectural design. However, one baud can be made to represent more than one bit per second. (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. file maintenance. development methodology. A platform includes, but is not limited to the operating system or executive software, communication software, microprocessor, network, input/output hardware, any generic software libraries, database management, user interface software, and the like. Contrast with network database, flat file. See: abstraction, information hiding, software engineering. system analysis. Syn: "big bang" integration. coding. Contrast with demodulation. The transmission capacity of a computer channel, communications line or bus. (NBS) A method to determine test set thoroughness by measuring the extent to which a test set can discriminate the program from slight variants [mutants] of the program. A registered trademark of Digital Research. A high speed computer in a network that is shared by multiple users. menu. (ANSI) Pertaining to an attribute, value, or option that is assumed when none is explicitly specified. A structured software design technique, breaking a system into components to facilitate design and development. Standards published by U.S. Department of Commerce, National Institute of Standards and Technology, formerly National Bureau of Standards. modeling. megahertz. (IEEE) A diagram that identifies the modules in a system or computer program and shows which modules call one another. (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. See: assembler, interpreter, cross-assembler, cross-compiler. A sequence of actions the user should take to avoid a problem or system limitation until the computer program is changed. It is expressed in cycles per second [Hz], and also is often stated in bits or bytes per second. The other system is considered as the standard of comparison. FDA-iRISK provides an option for using DALY, QALY loss or COI as a health metric. hazard severity. Geneva, Switzerland. Glossary. This technique can also be applied to other software and configuration items. (2) A functional programmable unit that consists of one or more associated processing units and peripheral equipment, that is controlled by internally stored programs, and that can perform substantial computations, including numerous arithmetic operations, or logic operations, without human intervention. touch sensitive. The use of computers to design products. specification, test case. The hardware and software which must be present and functioning for an application program to run [perform] as intended. Control Program for Microcomputers. error detection. (IEEE) A record of the name and values of variables accessed or changed during the execution of a computer program. Contrast with data validation. This is accomplished through I/0 ports and devices. preliminary design. See: TCP/IP. (2) A feedback control system in which at least one of the system signals represents a mechanical motion. certification. A software tool used to test output data reduction, formatting, and printing. usability. (IEEE) An aggregation of hardware, software, or both that is designated for configuration management and treated as a single entity in the configuration management process. See: static analysis. job. system design. (2) A condition or capability that must be met or possessed by a system or system component to satisfy a contract, standard, specification, or other formally imposed documents. design description. (IEEE) A mode of operation in which two or more tasks are executed in an interleaved manner. It typically includes functional requirements, performance requirements, interface requirements, design requirements [attributes and constraints], development [coding] standards, etc. (2) The compiler takes the finished source code listing as input and outputs the machine code instructions that the computer must have to execute the program. (IEEE) A diagram that identifies modules, activities, or other entities in a system or computer program and shows how larger or more general entities break down into smaller, more specific entries. software review. For more than 23 years, Praxis Life Sciences has been helping Pharmaceutical, Medical Device, and Biotechnology companies get their complex projects done right. In object oriented programming, A self contained module [encapsulation] of data and the programs [services] that manipulate [process] that data. Syn: flow diagram. It is non-standard ASCII. (2) In configuration management, the functional and physical characteristics of hardware or software as set forth in technical documentation or achieved in a product. (IEEE) Documentation specifying the scope, approach, resources, and schedule of intended testing activities. (IEEE) A computer program that translates programs [source code files] written in assembly language into their machine language equivalents [object code files]. The selection criterion is to pick values that seem likely to cause errors. The National Computer Systems Laboratory conducts research and provides, among other things, the technical foundation for computer related policies of the Federal Government. (2) A course of reasoning showing that a certain result is a consequence of assumed premises. byte. See: functional design. (1) (IEEE) A data value that corresponds to a minimum or maximum input, internal, or output value specified for a system or component. See: static analysis. hazard. linkage editor. system. design review. (IEEE) (1) The degree to which a system or component has a design or implementation that is difficult to understand and verify. See: execution trace, subroutine trace, symbolic trace, variable trace. assertion. American National Standards Institute. bandwidth, as well as by its actual lower and upper limits; e.g., a 10 MHz band in the 100 to 110 MHz range. macroinstruction. (2) (IEEE) A control flow diagram in which suitably annotated geometrical figures are used to represent operations, data, or equipment, and arrows are used to indicate the sequential flow from one to another. (NIST) Checking of user- embedded statements that assert relationships between elements of a program. virtual memory system. analog-to-digital converter. (DOD) The aggregate probability of occurrence of the individual events that create a specific hazard. See: ASCII. Testing designed to challenge a system's ability to manage the maximum amount of data over a period of time. specification, functional. Contrast with testing, unit; testing, system. FDA Glossary list of computer and software terms with definitions from IEEE, ANSI, ISO, NIST, NBS, and various other sources A PRAXIS LIFE SCIENCES knowledge center & resource +1 (847) 295-7160 serial. Praxis is a division of Treximo. life cycle methodology. See: execution trace, retrospective trace, subroutine trace, symbolic trace. bubble chart. traceability matrix. See: error guessing. Hardware used to read from or write to a hard disk. (1) (NBS) Use of an executable model to represent the behavior of an object. (3) (Webster) To prove to be true by demonstration. driver. The plan typically describes work to be done, resources required, methods to be used, the configuration management and quality assurance procedures to be followed, the schedules to be met, the project organization, etc. This term is derived from the term "picture element". See: anomaly, bug, defect, error, exception. test driver. (2) The ability of a program to perform its required functions accurately and reproducibly under stated conditions for a specified period of time. (IEEE) A mode of operation in which two or more programs are executed in an interleaved manner by a single CPU. measurement. Typically one to four bytes long, depending on the make of computer. (1) The suspension of a process to handle an event external to the process. 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. Traditional computer architecture that operates with large sets of possible instructions.
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