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GUIDELINES ON VALIDATION APPENDIX 5 VALIDATION OF ...

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. The draft 27 may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any 28 form or by any means outside these individuals and organizations (including the organizations' concerned staff and member 29 organizations) without the permission of the World Health Organization.

226 design, execution and commissioning of a design project (see also International Society for 227 Pharmaceutical Engineering (ISPE) Baseline: a risk based approach to compliant GXP 228 computerized systems GAMP). The left-hand edge of the V is where the project is defined and 229 specified in greater detail. The bottom point of the V is the ...

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