计算机术语 验证 validation,FDA-Software-Validation软件验证指南.pdf

FDA-Software-Validation软件验证指南

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