process control, and corrective and preventive action. GHTF Study Group 3 - Quality Management Systems Process Validation Guidance – January 2004 Page 6 The interrelationship of design control and process development may, for some technologies, be very closely related. For others the relationsh...
(USA), Canada, Japan and Australia. The document is intended to provide non-binding guidance to regulatory authorities for use in the regulation of medical devices, and has been subject to consultation throughout its development. There are no re strictions on the reproduction, distribution or ...
GHTF-SG3-N99-10-2004过程确认指南-英文文.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 Force Date: Edition 2 - January 20
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 “...
GHTF Study Group 3 - Quality Management Systems Process Validation Guidance– January 2004 Page 19 ROBUST DESIGN Robust O U T P U T Sensitive INPUT Figure 9: Robust design Another important tool is a control chart. Control Chart Worst Case Upper Spec (Acceptance) Limit Control (Action) Level...
devices. The purpose of such guidance is to harmonize the documentation and procedures that are used to assess whether a medical device, including IVD medical device conforms to the regulations that apply in each jurisdiction. Eliminating differences between jurisdictions decreases the cost of gaining ...
ProcesscontrolValidationaverageusedSealervariationproductresultsQuality 系统标签: 英文版validation指南ghtf验证validations GHTF/SG3/N99-10:2004(Edition2)FINALDOCUMENTTitle:QualityManagementSystems-ProcessValidationGuidanceAuthoringGroup:SG3Endorsedby:TheGlobalHarmonizationTaskForceDate:Edition2-January2004TaisukeHojo,GHTF...
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
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, translation or use of this document. However, incorporation of this ...
This document providesguidance in relation to: i)the circumstances where a post-market clinical follow-up study is indicated; ii)the general principles of post-market clinical follow-up studies involving medical devices; and iii)the use of study information, including, for example, to provide info...