《FDA_软件认证指南_Software_Validation》.pdfVIP

General Principles of Software Validation; Final Guidance for Indust... Page 1 of 47 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 Preface Public Comment /cdrh/comp/guidance/938.html 2/16/2002 General Principles of Software Validation; Final Guidance for Indust... Page 2 of 47 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