- The New IEEE Standard Dictionary of Electrical and Electronics Terms, IEEE Std. 100-1992.
- IEEE Standards Collection, Software Engineering, 1994 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 1025, Fault 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 Approach, Third Edition, McGraw-Hill, Inc., 1992.
- Myers, G., The Art of Software Testing, Wiley Interscience, 1979.
- Beizer, B., Software Testing Techniques, Second Edition, Van Nostrand Reinhold, 1990.
- Additional general references used in developing some definitions are:
- Bohl, M., Information Processing, Fourth Edition, Science Research Associates, Inc., 1984.
- Freedman, A., The Computer Glossary, Sixth Edition, American Management Association, 1993.
- McGraw-Hill Electronics Dictionary, Fifth Edition, 1994, McGraw-Hill Inc.
- McGraw-Hill Dictionary of Scientific & Technical Terms, Fifth Edition, 1994, McGraw-Hill Inc..
- Webster's New Universal Unabridged Dictionary, Deluxe Second Edition, 1979.
The bulk of this information was obtained from FDA.gov.