FDA-Software-Validation软件验证指南.pdf

General Principles of Software Validation; Final Guidance for Industry and FDA Staff 软件验证的基本原理； 企业和FDA人员的最终指导准则 Document issued on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“1997年6月9 日的1.1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 Public Comment 公众评论（意见/ 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 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@. （略） Additional Copies 额外话题 CDRH Additional copies are available from the Internet at: /MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM085281.htm. You may also send an e-mail request to dsmica@ 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 (