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General Principles of Software
Validation; Final Guidance for
Industry and FDA Staff
Document issued on: January 11, 2002
This document supersedes the draft document, "General Principles of
Software Validation, Version 1.1, dated June 9, 1997.
U.S. Department Of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research
Page ii
General Principles of Software Validation
Guidance for Industry and FDA Staff
Preface
Public Comment
Comments and suggestions may be submitted at any time for Agency consideration to Dockets
Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated.
For questions regarding the use or interpretation of this guidance which involve the Center for Devices
and Radiological Health (CDRH), contact John F. Murray at (301) 594-4659 or email
jfm@cdrh.fda.gov
For questions regarding the use or interpretation of this guidance which involve the Center for Biologics
Evaluation and Research (CBER) contact Jerome Davis at (301) 827-6220 or email
davis@cber.fda.gov.
Additional Copies
CDRH
Additional copies are available from the Internet at:
http://www.fda.gov/cdrh/comp/guidance/938.pdf or via CDRH Facts-On-Demand. In order to receive this document via your fax machine, call the CDRH Facts-On-Demand system at 800- 899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number 938 followed by the pound sign (#). Follow the remaining voice prompts to complete your request.
CBER
Additional copies are available from the Internet at: http://www.fda.gov/cber/guidelines.htm, by
writing to CBER, Office of Communication, Training, and Manufacturers' Assistance (HFM- 40), 1401 Rockville Pike, Rockville, Maryland 20852-1448, or by telephone request at 1- 800-835-5709 or 301-827-1800.
Page iii
General Principles of Software Validation
Guidance for Industry and FDA Staff
Table of Contents
SECTION 1. PURPOSE..............................................................................................................1
SECTION 2. SCOPE...................................................................................................................1
2.1. Applicability........................................................................................................................ 2 2.2. Audience............................................................................................................................. 2 2.3. THE LEAST BURDENSOME APPROACH................................................................... 2 2.4. Regulatory Requirements for Software Validation.......................................................... 3 2.4. Quality System Regulation vs Pre-Market Submissions................................................. 4
SECTION 3. CONTEXT FOR SOFTWARE VALIDATION...................................................5
3.1. Definitions and Terminology............................................................................................. 5
3.1.1 Requirements and Specifications................................................................................... 5 3.1.2 Verification and Validation........................................................................................... 6 3.1.3 IQ/OQ/PQ...................................................................................................................... 7
3.2. Software Development as Part of System Design............................................................ 7 3.3. Software is Different from Hardware................................................................................ 8 3.4. Benefits of Software Validation......................................................................................... 9 3.5 Design Review...................................................................................................................9
SECTION 4. PRINCIPLES OF SOFTWARE VALIDATION...............................................11
4.1. Requirements................................................................................................................... 11 4.2. Defect Prevention............................................................................................................ 11 4.3. Time and Effort................................................................................................................ 11 4.4. Software Life Cycle.......................................................................................................... 11 4.5. Plans.................................................................................................................................. 12 4.6. Procedures........................................................................................................................ 12 4.7. Software Validation After a Change............................................................................... 12 4.8. Validation Coverage........................................................................................................ 12 4.9. Independence of Review.................................................................................................. 12
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