ISPE GAMP指南《数据完整性源于设计》 (1).pdfVIP

For individual use only. © Copyright ISPE 2020. All rights reserved. ISPE, the Developers of GAMP® RECORDS AND DATA INTEGRITY GOOD PRACTICE GUIDE: Data Integrity by Design Disclaimer: ® The ISPE GAMP RDI Good Practice Guide: Data Integrity by Design provides practical guidance to support pharmaceutical organizations achieve good data governance together with the efficient and effective implementation and operation of compliant GxP computerized systems. This Guide is solely created and owned by ISPE. It is not a regulation, standard or regulatory guideline document. ISPE cannot ensure and does not warrant that a system managed in accordance with this Guide will be acceptable to regulatory authorities. Further, this Guide does not replace the need for hiring professional engineers or technicians. Limitation of Liability In no event shall ISPE or any of its affiliates, or the officers, directors, employees, members, or agents of each of them, or the authors, be liable for any damages of any kind, including without limitation any special, incidental, indirect, or consequential damages, whether or not advised of the possibility of such damages, and on any theory of liability whatsoever, arising out of or in connection with the use of this information. © Copyright ISPE 2020. All rights reserved. All rights reserved. No part of this document may be reproduced or copied in any form or by any means – graphic, electronic, or mechanical, including photocopying, taping, or information storage and retrieval systems – without written permission of ISPE. All trademarks used are acknowledged. ISBN 978-1-946964-34-2 For individual use only.