General principles of software validation : final guidance for industry and FDA staff
Published:
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2002]
Title from PDF title page (viewed on May 27, 2009). "Supersedes the draft document "General principles of software validation["], version 1.1, dated June 9,1997". "Document issued on: January 11, 2002".
Bibliography Note:
Includes bibliographical references (pages 35-42).
Technical Details:
Mode of access: Internet at the FDA CBER web site. Address as of 5/27/09: http://www.fda.gov/cdrh/comp/guidance/938.pdf ; current access is available via PURL.