【中文版】GHTF Process Validation guidance工艺验证指南
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 “...
- Process Validation Guidance. 2.4 Process Validation (Definition) Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined requirements. GHTF SG3 Training : Toronto May 14-16, 2009 5 SG3/N99- 10 (Edition 2) Quality SG3/N99- 10 (...
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
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...
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 ...
processes titled ISO 9000 Introduction and support package: Guidance on outsourced processes. Clause 2.2 of this document states: The intent of Clause 4.1 of ISO 9001:2000 is to emphasize that when an organization chooses to outsource (either permanently or temporarily) a process that affects produc...
The document 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, incorporation of this document, 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 ...