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General principles of software validation : final guidance for industry and FDA staff.

Author: Center for Biologics Evaluation and Research (U.S.)
Publisher: 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]
Edition/Format:   eBook : Document : National government publication : English
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Material Type: Document, Government publication, National government publication, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Center for Biologics Evaluation and Research (U.S.)
OCLC Number: 352926751
Notes: 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."
Description: iv, 43 pages : digital, PDF file
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.

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