【中文版】GHTF Process Validation guidance工艺验证指南
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 ...
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 “...
英文版validation指南ghtf验证validations GHTF/SG3/N99-10:2004(Edition2)FINALDOCUMENTTitle:QualityManagementSystems-ProcessValidationGuidanceAuthoringGroup:SG3Endorsedby:TheGlobalHarmonizationTaskForceDate:Edition2-January2004TaisukeHojo,GHTFChairThedocumenthereinwasproducedbytheGlobalHarmonizationTaskForce,avoluntarygroup...
Quality Management Systems – Process ValidationGuidanceüüAuthoring Group: SG3 3 Endorsed by: The Global Harmonization Task Force(GHTF)Date:Edition 2 - January ...
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
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
GHTF/SG3/N99-10:2004 (Edition 2) FINAL DOCUMENT Title: Quality Management Systems - Process Validation Guidance Authorin g Group: En dorsed by: Date: SG3 The Global Harmonization Task Force Edition 2 - January 2004 Taisuke Hojo, GHTF Chair The document herein was produced by the Global Har...
Update on the Global Harmonisation process for medical-devices regulation, and on progress with the global medical device nomenclature This article discusses about a set of guidance documents, to be provided by GHTF (Global Harmonisation Task Force), which will be available within the next... M ...
10.3.ProcessValidation 11.Servicing 12.AnalysisofData 13.CorrectiveandPreventiveActions(CAPA) Annexes: AnnexA–AnExampleofaRiskChartforCommunicatingInternalRiskManagement Activities GHTFStudyGroup3SG3/N15R8Page3of23 RiskManagementGuidance AnnexB–FlowChart–RiskManagementActivitiesinDesignandDevelopment ...