United States Government Publishing Office publisher pbl distributor dst United States Health and Human Services Department Food and Drug Administration author aut Government Organization text government publication eng GOVPUB Executive Agency Publications executive 2023-06-06 Health and Human Services Department 2002-01-01 monographic harvested born digital 47 digital object pages HE 20.4802:SO 2 https://www.govinfo.gov/app/details/GOVPUB-HE20_4000-PURL-LPS113110 P0b002ee1bea8cc84 000640032 https://purl.fdlp.gov/GPO/LPS113110 (OCoLC)352926751 DGPO 2023-06-06 2026-07-01 GOVPUB-HE20_4000-PURL-LPS113110 machine generated eng fdlp HE20_4000 GOVPUB-HE20_4000-PURL-LPS113110 PURL-LPS113110 GOVPUB This content was harvested from online sources of the original hosting or authoring agency and may not reflect current policy. As Federal agencies add publications to their websites, or report new publications to GPO per statutory mandate (44 U.S.C. §§ 1710, 1902-1903), GPO ensures long-term preservation of and access to the content. 2002 PERM_INGEST_04282022 LPS113110 https://www.govinfo.gov/app/details/GOVPUB-HE20_4000-PURL-LPS113110 https://www.govinfo.gov/content/pkg/GOVPUB-HE20_4000-PURL-LPS113110/pdf/GOVPUB-HE20_4000-PURL-LPS113110.pdf Final Guidance for Industry and FDA Staff Computer software Validation United States Center for Devices and Radiological Health (U.S.) 0499-T-02 (online) Center for Biologics Evaluation and Research (U.S.) mdu 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] monographic

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iv, 43 pages : digital, PDF file HE 20.4802:SO 2 0499-T-02 (online) text bibliography eng 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". Includes bibliographical references (pages 35-42). 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. Computer software Validation United States Center for Devices and Radiological Health (U.S.) https://purl.fdlp.gov/GPO/LPS113110 https://catalog.gpo.gov/fdlpdir/locate.jsp?ItemNumber=0499-T-02&SYS=000640032 final guidance for industry and FDA staff final guidance for industry and FDA staff