Transcription of Computer System Validation Basics
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Computer System Validation Basics
1925 West Field Court, Suite 125, Lake Forest, IL 60045 Validation Center | +1(847) System Validation BasicsBy Praxis Life SciencesReproduction or re transmission in any form or by any means, electronic or mechanicalwithout prior written permission from Praxis is prohibited. 2015 Praxis Life Sciences. All rights Center Life Sciences | West Field Court, Suite 125, Lake Forest, IL 60045 | +1 (847) 295 71601 Computer System Validation Basics Copyright 2015 by Praxis Life Sciences. All rights reserved. No part of these materials may be reproduced or transmitted in any form without the written permission of PraxisYour Praxis FacilitatorValidation Center 2015 Praxis Life Sciences 2 Debra Bartel, MBA, CQA, PMP Principal, Praxis Life Sciences 25+ years experience specializing in software quality assurance, Validation and regulatory compliance, Information Systems project management, and process design.
for Medicinal Products 5.40 GMP related computerized systems should be validated. The depth andscopeof validationdependson thediversity,complexity criticality of the computerized application. PIC/SPE011‐1 Guide to Good DistributionPracticefor Medicinal Products Before a computerisedsystem is brought into use, it should be
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