Glossary of Computer System Software Development Terminology (8/9. Note: This document is reference material for investigators and other FDA personnel.
The document does not bind FDA, and does no confer any rights, privileges, benefits, or immunities for or on any person(s). INTRODUCTIONThis document is intended to serve as a glossary of terminology applicable to software development and computerized systems in FDA regulated industries.
Oracle acquired Sun Microsystems in 2010, and since that time Oracle's hardware and software engineers have worked side-by-side to build fully integrated systems and. Meet Inspiring Speakers and Experts at our 3000+ Global Events with over 600+ Conferences, 1200+ Symposiums and 1200+ Workshops on Medical, Pharma, Engineering. Computer software, or simply software, is a part of a computer system that consists of data or computer instructions, in contrast to the physical hardware from which.
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It will facilitate consistency in describing the requirements of the law and regulations applicable to such products and systems. It is also a resource for investigators who conduct inspections and investigations involving software and computerized systems. The organization of this document is primarily alphabetical. Acronyms are grouped at the beginning of each alphabetical section, and are followed by words, terms and phrases. Acronyms are expanded at the beginning of each alphabetical section and defined with the full term or phrase.
Four modifications are the grouping of terms and phrases in the domains of specifications, testing, qualification, and validation. Those related terms are located sequentially to assist the user in finding all defined terms in these domains, e. The terms are defined, as much as possible, using available standards. The source of such definitions appears immediately following the term or phrase in parenthesis, e. NIST). The source documents are listed below.
The New IEEE Standard Dictionary of Electrical and Electronics Terms, IEEE Std. IEEE Standards Collection, Software Engineering, 1. Edition, published by the Institute of Electrical and Electronic Engineers Inc. National Bureau of Standards [NBS] Special Publication 5. Validation, Verification, and Testing of Computer Software, 1. Federal Information Processing Standards [FIPS] Publication 1. Guideline For Lifecycle Validation, Verification, and Testing of Computer Software, 1.
Federal Information Processing Standards [FIPS] Publication 1. Guideline for Software Documentation Management, 1.
American National Standard for Information Systems, Dictionary for Information Systems, American National Standards Institute, 1. FDA Technical Report, Software Development Activities, July 1.
FDA Guide to Inspection of Computerized Systems in Drug Processing, 1. FDA Guideline on General Principles of Process Validation, May 1. Reviewer Guidance for Computer Controlled Medical Devices Undergoing 5. Review, Office of Device Evaluation, CDRH, FDA, August 1. HHS Publication FDA 9.
Preproduction Quality Assurance Planning. MIL- STD- 8. 82. C, Military Standard System Safety Program Requirements, 1.
JAN1. 99. 3. International Electrotechnical Commission, International Standard 1. Fault Tree Analysis. International Electrotechnical Commission, International Standard 8. Analysis Techniques for System Reliability - Procedure for Failure Mode and Effects Analysis [FMEA]. FDA recommendations, Application of the Medical Device GMP to Computerized Devices and Manufacturing Processes, May 1. Pressman, R., Software Engineering, A Practitioner's Approach, Third Edition, Mc.
Graw- Hill, Inc., 1. Myers, G., The Art of Software Testing, Wiley Interscience, 1. Beizer, B., Software Testing Techniques, Second Edition, Van Nostrand Reinhold, 1. Additional general references used in developing some definitions are: Bohl, M., Information Processing, Fourth Edition, Science Research Associates, Inc., 1. Freedman, A., The Computer Glossary, Sixth Edition, American Management Association, 1. Mc. Graw- Hill Electronics Dictionary, Fifth Edition, 1. Mc. Graw- Hill Inc.
Mc. Graw- Hill Dictionary of Scientific & Technical Terms, Fifth Edition, 1. Mc. Graw- Hill Inc. Webster's New Universal Unabridged Dictionary, Deluxe Second Edition, 1.
A - ADC. analog- to- digital converter. ALU. arithmetic logic unit. ANSI. American National Standards Institute. ASCII. American Standard Code for Information Interchange. The separation of the logical properties of data or function from its implementation in a computer program. See: encapsulation, information hiding, software engineering. ANSI) To obtain the use of a resource.
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. See: mishap. accuracy. IEEE) (1) A qualitative assessment of correctness or freedom from error. A quantitative measure of the magnitude of error. Contrast with precision.
CDRH) (3) The measure of an instrument's capability to approach a true or absolute value. It is a function of precision and bias. See: bias, precision, calibration. A software tool used to perform calculations or determine accuracy of computer manipulated program variables. A peripheral [output] device which translates electrical signals into mechanical actions; e.
See: servomechanism. IEEE) Software maintenance performed to make a computer program usable in a changed environment. Contrast with corrective maintenance, perfective maintenance. A number, character, or group of characters which identifies a given device or a storage location which may contain a piece of data or a program step. To refer to a device or storage location by an identifying number, character, or group of characters.
IEEE) An exception that occurs when a program calculates an address outside the bounds of the storage available to it. IEEE) (1) A finite set of well- defined rules for the solution of a problem in a finite number of steps. Any sequence of operations for performing a specific task.
IEEE) A software V& V task to ensure that the algorithms selected are correct, appropriate, and stable, and meet all accuracy, timing, and sizing requirements. Pertaining to a character set that contains letters, digits, and usually other characters such as punctuation marks. American National Standards Institute. West 4. 2nd Street, New York, N. Y. 1. 00. 36. An organization that coordinates the development of U. S. voluntary national standards for nearly all industries. It is the U. S. member body to ISO and IEC.
Information technology standards pertain to programming languages, electronic data interchange, telecommunications and physical properties of diskettes, cartridges and magnetic tapes. American Standard Code for Information Interchange. 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. Provides 1. 28 possible characters, the first 3. Since common storage is an 8- bit byte [2.
ASCII uses only 1. See: extended ASCII. Pertaining to data [signals] in the form of continuously variable [wave form] physical quantities; e. Contrast with digital. IEEE) A device that operates with variables represented by continuously measured quantities such as pressures, resistances, rotations, temperatures, and voltages.
Input related devices which translate an input device's [sensor] analog signals to the corresponding digital signals needed by the computer. Contrast with DAC [digital- to- analog converter]. See: analog, digital. To separate into elemental parts or basic principles so as to determine the nature of the whole. A course of reasoning showing that a certain result is a consequence of assumed premises. ANSI) The methodical investigation of a problem, and the separation of the problem into smaller related units for further detailed study.
IEEE) Anything observed in the documentation or operation of software that deviates from expectations based on previously verified software products or reference documents. See: bug, defect, error, exception, fault. See: application software.
IEEE) Software designed to fill specific needs of a user; for example, software for navigation, payroll, or process control. Contrast with support software; system software. IEEE) (1) The process of defining a collection of hardware and software components and their interfaces to establish the framework for the development of a computer system. See: functional design. The result of the process in (1).
See: software engineering. IEEE) The organizational structure of a system or component. See: component, module, subprogram, routine. ISO) An historical copy of a database saved at a significant point in time for use in recovery or restoration of the database. IEEE) A lasting collection of computer system data or other records that are in long term storage.