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21 CFR Part 11 Complete Guide to International Computer

Library of Congress Cataloging-in-Publication Data Lpez Orlando 21 CFR Part 11: complete guide to international computer validation compliance for the pharmaceutical industry/Orlando Lpez p cm Includes bibliographical references and index ISBN 0-8493-2243-X (alk paper) 1 Phar maceutical industry 2 Computer software— Validation 3 Computer programs—Verification I Title

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Computer systems validation: quality assurance risk management and regulatory compliance for pharmaceutical and healthcare companies Guy Wingate Both pervasive and ubiquitous computerized systems are now an integral component of every corporate strategy

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FDA to Prescribe New Drug Manufacturing Standards

FDA to Prescribe New Drug Manufacturing Standards First top-to-bottom review in 25 years to emphasize risk management principle Oct 18 2002 U S Food and Drug Administration (FDA) caught many drug makers by surprise when it announced in late August a broad-ranging initiative to overhaul how it regulates pharmaceutical manufacturing operations The announcement comes at a time when

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