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
Guidance for Industry and FDA Staff General Principles of Software Validation

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: www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/UCM085281.htm.
You may also send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the
guidance or send a fax request to 301-847-8149 to receive a hard copy. Please use the document
number (938) to identify the guidance you are requesting.

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.

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Guidance for Industry and FDA Staff General Principles of Software Validation

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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