Transcription of General Principles of Software Validation; Final …
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Copyright eCompliance 2015 1 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 , dated June 9, 1997. Department Of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research Copyright eCompliance 2015 2 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
当局に対する懸念事項としてDockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630
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