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" EU Annex 11 guide to computer validation compliance for the Worldwide Health Agency GMP "
Orlando López ; contributors, R.D. McDowall [and three others].
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BL
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614974
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dltt
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López, Orlando
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EU Annex 11 guide to computer validation compliance for the Worldwide Health Agency GMP\ Orlando López ; contributors, R.D. McDowall [and three others].
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1 online resource :: illustrations
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| ISBN
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9781482243635
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9781482243628
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Includes bibliographical references.
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| Abstract
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The purpose of Annex 11 is to provide the EMA healthcare industry with consistent criteria for effective implementation, control, and use of computer systems. This book supplies practical information to facilitate compliance with computer system GMP requirements, while highlighting and integrating the Annex 11 guidelines into the computer compliance program. It details a practical approach to increase efficiency and to ensure that software development and maintenance are achieved correctly. Examples from laboratory, clinical, and manufacturing computer systems are included as well as a discussion of electronic record integrity associated with stored information. Comparisons to the Annex 11 with key worldwide computer systems regulations and guidelines, including U.S. Food and Drug Administration, Canada, Australia TGA, PIC/S, and China FDA are shown. --
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Computer software-- Validation.
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Computer security.
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McDowall, R. D.
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Books24x7, Inc.
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