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Title General principles of software validation [electronic resource] : final guidance for industry and FDA staff

Imprint 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]

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:SO 2    ---  Available
Description iv, 43 p. : digital, PDF file
System Details Mode of access via the FDA CBER web site.
Note 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 Includes bibliographical references (p. 35-42).
Subject Computer software -- Validation -- United States.
Center for Devices and Radiological Health (U.S.)
Added Author Center for Biologics Evaluation and Research (U.S.)
Gpo Item No. 0499-T-02 (online)
Sudoc No. HE 20.4802:SO 2

 
    
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