Glossary
In 1995 the FDA 's Office of Regulatory Affairs (ORA) published a "Glossary of Computerized System and Software Development Terminology". It is available online at www.fda.gov/ora. This document is intended to serve as a glossary of terminology applicable to software development and computerized systems in FDA regulated industries. It is to 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. A sample of relevant terms is given below.
computer. (IEEE) (1) A functional unit that can perform substantial computations, including numerous arithmetic operations, or logic operations, without human intervention during a run. (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.
computer system. (ANSI) a functional unit, consisting of one or more computers and associated peripheral input and output devices, and associated software, that uses common storage for all or part of a program and also for all or part of the data necessary for the execution of the program; executes user-written or user-designated programs; performs user-designated data manipulation, including arithmetic operations and logic operations; and that can execute programs that modify themselves during their execution. A computer system may be a stand-alone unit or may consist of several interconnected units. See: computer, computerized system.
computerized system. Includes hardware, software, peripheral devices, personnel, and documentation; e.g., manuals and Standard Operating Procedures. See: computer, computer system.
quality assurance. (1) (ISO) The planned systematic activities necessary to ensure that a component, module, or system conforms to established technical requirements. (2) All actions that are taken to ensure that a development organization delivers products that meet performance requirements and adhere to standards and procedures. (3) The policy, procedures, and systematic actions established in an enterprise for the purpose of providing and maintaining some degree of confidence in data integrity and accuracy throughout the life cycle of the data, which includes input, update, manipulation, and output. (4) (QA) The actions, planned and performed, to provide confidence that all systems and components that influence the quality of the product are working as expected individually and collectively.
quality assurance, software. (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. (2) A set of activities designed to evaluate the process by which products are developed or manufactured.
quality control. The operational techniques and procedures used to achieve quality requirements.
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Dr. Teri Stokes
GXP International
131 Sudbury Road
Concord, MA 01742 USA
Tel: +1-978-287-4393
Fax: +1-978-369-5620
Email: drstokes@gxpinternational.com |
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