FDA 软件认证指南 Software Validation

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.

Preface

Public Comment

U.S. Department Of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health Center for Biologics Evaluation and Research

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@.

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@.

Additional Copies

CDRH

Additional copies are available from the Internet at:

/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:

/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.

Table of Contents

SECTION 1. PURPOSE

SECTION 2. SCOPE

2.1. Applicability

2.2. Audience

2.3. THE LEAST BURDENSOME APPROACH

2.4. Regulatory Requirements for Software Validation

2.4. Quality System Regulation vs Pre-Market Submissions SECTION

3. CONTEXT FOR SOFTWARE VALIDATION

3.1. Definitions and Terminology

3.1.1 Requirements and Specifications

3.1.2 Verification and Validation

3.1.3 IQ/OQ/PQ

3.2. Software Development as Part of System Design

3.3. Software is Different from Hardware

3.4. Benefits of Software Validation

3.5 Design Review

SECTION 4. PRINCIPLES OF SOFTWARE VALIDATION

4.1. Requirements

4.2. Defect Prevention

4.3. Time and Effort

4.4. Software Life Cycle

4.5. Plans

4.6. Procedures

4.7. Software Validation After a Change

4.8. Validation Coverage

4.9. Independence of Review

4.10. Flexibility and Responsibility

SECTION 5. ACTIVITIES AND TASKS