Transcription of GUIDELINES ON VALIDATION APPENDIX 5 …
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GUIDELINES ON VALIDATION APPENDIX 5 …
Working document May 2016 Draft document for comment 1 GUIDELINES ON VALIDATION APPENDIX 5 2 VALIDATION OF COMPUTERIZED SYSTEMS 3 (May 2016) 4 DRAFT FOR COMMENTS 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 World Health Organization 2016 25 All rights reserved. 26 This draft is intended for a restricted audience only, the individuals and organizations having received this draft.
Working document QAS/16.667 page 5 168 1. INTRODUCTION AND SCOPE 169 170 1.1 Computerized systems should be validated at the level appropriate for their intended use and in accordance with quality risk management principles.171 This applies to …
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GAMP, Qualification, GAMP 5, Quality Risk Management, Approach, GAMP 5: A Quality Risk Management Approach to, GAMP 5 ARiskA Risk-Based Approach toBased, GAMP 5 ARiskA Risk-Based Approach toBased Approach, Compliant GxPCompliant GxP Computerized Systems, INTEGRATED SOLUTIONS, 11; other guidelines Orlando López