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Quality Management systems - Process Validation …
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 Global Harmonization Task Force, a voluntary group of representatives from medical device regulatory agencies and the regulated industry. 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 restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in part or in whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the Global Harmonization Task Force.
GHTF Study Group 3 - Quality Management Systems Process Validation Guidance – January 2004 Page 2 Process Validation Guidance Contents 0 Introduction
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GUIDELINES ON VALIDATION APPENDIX 6, Process, Guidelines on validation – appendix 6, Validation, Systems, GUIDELINES ON VALIDATION APPENDIX 5, Guidelines on validation – appendix 5, Systems Engineering Management Plan, Process Validation for Medical Devices, Quality, A Quality Risk Management Approach to, Quality Risk Management QRM, Management, 2000 - A Process Interaction Matrix - A, 2000 - A Process Interaction Matrix - A Case