Transcription of GUIDELINES ON VALIDATION APPENDIX 5 VALIDATION OF ...
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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.
Computerized system 191 validation activities should address both system configuration as well as any custom-developed 192 elements. 193 194 1.5 Computerized systems should be maintained in the validated state with risk-based controls appropriate to the different195 stages of the system life cycle. These stages include system
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