GHTF-SG3-N99-10-2004 Process Validation Guidance外文电子书籍.pdf,GHTF/SG3/N99-10:2004 (Edition 2) FINAL DOCUMENT Title: Quality Management Systems - Process Validation Guidance Authoring Group: SG3 Endorsed by: The Global Harmonization Task Force Date: E
内容提示: GHTF/SG3/N99-10:2004 (Edition 2) FINAL DOCUMENT Title: Quality Management Systems - Process Validation Guidance Authoring Group: SG3 Endorsed by: The Global Harmonization Task Force Date: Edition 2 - January 2004 Taisuke Hojo, GHTF Chair The document herein was produced by the ...
【中文版】GHTF Process Validation guidance工艺验证指南
Quality Management Systems – Process ValidationGuidanceüüAuthoring Group: SG3 3 Endorsed by: The Global Harmonization Task Force(GHTF)Date:Edition 2 - January ...
The Process Validation Guidance has been revised in sections 0 through 3.4, Figure 1 and Annex B. The revisions can be generalized in two categories: 1.) Editorial revision of terminology to be consistent with ISO 13485:2003 (i.e., “quality system” to “quality management system” and “...
Quality Management Systems - Process Validation Guidance _GHTF 2_字体淡.doc,GHTF/SG3/N99-10:2004 (Edition 2) FINAL DOCUMENT Title: Quality Management Systems - Process Validation Guidance Authoring Group: SG3 Endorsed by: The Global Harmonization Task Fo
“QualityManagementSystems–ProcessValidationGuidance”,originallyfinalizedin1999,isbeingrepublishedas“GHTF/SG3/N99-10:2004(Edition2)”afterrevisionsduetothechangesinISO13485:2003,whichisutilizedinsomeregulatorysystems.TheProcessValidationGuidancehasbeenrevisedinsections0through3.4,Figure1andAnnexB.Therevisionscanbe...
10.3.ProcessValidation 11.Servicing 12.AnalysisofData 13.CorrectiveandPreventiveActions(CAPA) Annexes: AnnexA–AnExampleofaRiskChartforCommunicatingInternalRiskManagement Activities GHTFStudyGroup3SG3/N15R8Page3of23 RiskManagementGuidance AnnexB–FlowChart–RiskManagementActivitiesinDesignandDevelopment ...
ument is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development. There are no restrictions on the reproduction, distribution or use of this document; however, in- ...
GHTF/SG3/N99-10:2004 (Edition 2) FINAL DOCUMENT Title: Quality Management Systems - Process Validation Guidance SG3 The Global Harmonization Task Force Edition 2 - January 2004 Authoring Group: Endorsed by: Date: Taisuke Hojo, GHTF Chair The document herein was produced by the Global ...