sábado, 26 de janeiro de 2019

GLS: A Glossary of Computer System Software Development Terminology (8/95) from... FDA

Inspection Guides > Glossary of Computer System Software Development Terminology (8/95)

...And a list of sources (standards and books) for those terms FFR, quoting:

"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.g. (NIST). The source documents are listed below.
The New IEEE Standard Dictionary of Electrical and Electronics Terms, IEEE Std. 100-1992.
IEEE Standards CollectionSoftware Engineering1994 Edition, published by the Institute of Electrical and Electronic Engineers Inc.
National Bureau of Standards [NBS] Special Publication 500-75 Validation, Verification, and Testing of Computer Software, 1981.
Federal Information Processing Standards [FIPS] Publication 101, Guideline For Lifecycle Validation, Verification, and Testing of Computer Software, 1983.
Federal Information Processing Standards [FIPS] Publication 105, Guideline for Software Documentation Management, 1984.
American National Standard for Information Systems, Dictionary for Information Systems, American National Standards Institute, 1991.
FDA Technical Report, Software Development Activities, July 1987.
FDA Guide to Inspection of Computerized Systems in Drug Processing, 1983.
FDA Guideline on General Principles of Process Validation, May 1987.
Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review, Office of Device Evaluation, CDRH, FDA, August 1991.
HHS Publication FDA 90-4236, Preproduction Quality Assurance Planning.
MIL-STD-882C, Military Standard System Safety Program Requirements, 19JAN1993.
International Electrotechnical Commission, International Standard 1025Fault Tree Analysis.
International Electrotechnical Commission, International Standard 812, 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 1992.
Pressman, R., Software Engineering, A Practitioner's ApproachThird Edition, McGraw-Hill, Inc., 1992.
Myers, G., The Art of Software Testing, Wiley Interscience, 1979.
Beizer, B., Software Testing TechniquesSecond Edition, Van Nostrand Reinhold, 1990.
Additional general references used in developing some definitions are:
Bohl, M., Information ProcessingFourth Edition, Science Research Associates, Inc., 1984.
Freedman, A., The Computer GlossarySixth Edition, American Management Association, 1993.
McGraw-Hill Electronics Dictionary, Fifth Edition, 1994, McGraw-Hill Inc.
McGraw-Hill Dictionary of Scientific & Technical TermsFifth Edition, 1994, McGraw-Hill Inc..
Webster's New Universal Unabridged DictionaryDeluxe Second Edition, 1979."