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Managing the Documentation Maze: Answers to Questions You Didnt Even Know to Ask

Posted on 2010-05-16




Name:Managing the Documentation Maze: Answers to Questions You Didnt Even Know to Ask
ASIN/ISBN:0470467088
Publish Date:Wiley (March 22, 2010)
Pages:474 pages
File size:1.5 Mb
Publish Date: Wiley (March 22, 2010)
ISBN: 0470467088
Pages: 474 pages
File Type: PDF
File Size: 1.5 MB
   Managing the Documentation Maze: Answers to Questions You Didnt Even Know to Ask

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This book deals with a topic of critical importance for compliance with record-keeping regulations in pharmaceutical and medical device industries. It presents more than 750 questions and answers about documentation management, whether electronic or paper-based. It defines, through a Q&A approach, what document management actually is, and why it should be a core discipline in the industry. Questions and responses also address electronic system selection and validation, system security, user accountability, and audit trails, as well as standard operating procedures for supporting document systems. Finally, responses demystify the meaning of binding regulations.

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