General Principles of Software Validation; Final Guidance for Industry and FDA Staff 软件验证的基本原理；软件验证的基本原理； 企业和企业和FDA人员的最终指导准则人员的最终指导准则 Document issued on发布日期发布日期: January 11, 2002 This document supersedes the draft document, “General Principles of Software Validation, Version 1.1, dated June 9, 1997. 本文件取代之前的草案“本文件取代之前的草案“1997年年6月月9日的日的1.1版软件验证的基本原理版软件验证的基本原理 ” U.S. Department Of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research Preface 前言前言 Public Comment 公众评论（意见公众评论（意见/问题）问题） 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 jfmcdrh.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 daviscber.fda.gov. （略） Additional Copies 额外话题额外话题 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 dsmicafda.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, bywriting to CBER, Office of Communication, Training, and Manufacturers Assistance (HFM40), 1401 Rockville Pike, Rockville, Maryland 20852-1448, or by telephone request at 1800-835-5709 or 301-827-1800. （略） Table of Contents 目目 录录 SECTION 1. PURPOSE 第 1 部分 目的 4 SECTION 2. SCOPE 第 2 部分 范围 . 4 2.1. APPLICABILITY 适用范围 5 2.2. AUDIENCE 公众 . 5 2.3. THE LEAST BURDENSOME APPROACH 最简便的方法 . 5 2.4. REGULATORY REQUIREMENTS FOR SOFTWARE VALIDATION 软件验证的监管要求 6 2.5. QUALITY SYSTEM REGULATION VS PRE-MARKET SUBMISSIONS 质量系统法规 VS 上市前申请 . 7 SECTION 3. CONTEXT FOR SOFTWARE VALIDATION 软件验证的背景 . 8 3.1. DEFINITIONS AND TERMINOLOGY 定义和术语 . 8 3.1.1 Requirements and Specifications 法规要求和标准规范 8 3.1.2 Verification and Validation 软件确认和验证 . 9 3.1.3 IQ/OQ/PQ 10 3.2. SOFTWARE DEVELOPMENT AS PART OF SYSTEM DESIGN 软件设计-软件开发 . 11 3.3. SOFTWARE IS DIFFERENT FROM HARDWARE 软件不同于硬件. 11 3.4. BENEFITS OF SOFTWARE VALIDATION 软件验证的益处 . 13 3.5 DESIGN REVIEW 设计评审 13 SECTION 4. PRINCIPLES OF SOFTWARE VALIDATION 软件验证的法则 14 4.1. REQUIREMENTS 法规要求 . 14 4.2. DEFECT PREVENTION 缺陷预防 . 14 4.3. TIME AND EFFORT 时间和尝试 14 4.4. SOFTWARE LIFE CYCLE 软件生命周期 . 15 4.5. PLANS 计划 . 15 4.6. PROCEDURES 规程 15 4.7. SOFTWARE VALIDATION AFTER A CHANGE 变更后的软件验证 . 15 4.8. VALIDATION COVERAGE 验证范围 . 15 4.9. INDEPENDENCE OF REVIEW 独立评审. 16 4.10. FLEXIBILITY AND RESPONSIBILITY 灵活性和责任 16 SECTION 5. ACTIVITIES AND TASKS 活动和任务 . 17 5.1. SOFTWARE LIFE CYCLE ACTIVITIES 软件生命周期活动 . 17 5.2. TYPICAL TASKS SUPPORTING VALIDATION 典型的任务辅助性验证 17 5.2.1. Quality Planning 质量计划 18 5.2.2. Requirements 需求 19 5.2.3. Design 设计 21 5.2.4. Construction or Coding . 23 5.2.5. Testing by the Software Developer 软件开发者执行的测试 25 5.2.6. User Site Testing 用户现场测试 31 5.2.7. Maintenance and Software Changes 维护和软件变更 33 SECTION 6. VALIDATION OF AUTOMATED PROCESS EQUIPMENT AND QUALITY SYSTEM SOFTWARE 自动化 过程验证设备和质量系统软件 . 34 6.1. HOW MUCH VALIDATION EVIDENCE IS NEEDED? 需要多少验证依据 . 36 6.2. DEFINED USER REQUIREMENTS 定义用户需求. 37 6.3. VALIDATION OF OFF-THE-SHELF SOFTWARE AND AUTOMATED EQUIPMENT 成品软件和自动设备的验证 38 General Principles of Software Validation 软件验证的一般原则软件验证的一般原则 This document is intended to provide guidance. It represents the Agencys current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind Food and Drug Administration (FDA) or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. SECTION 1. PURPOSE 第第 1 部分部分 目的目的 This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0, supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June 9, 1997. 本指导概 括了FDA认为适用于医疗器械软件验证，或用于设计、开发，或生产医疗器械的软件验证的一般验 证原则。 SECTION 2. SCOPE 第第 2 部分部分 范围范围 This guidance describes how ce