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Managing the Documentation Maze

Name: Managing the Documentation Maze
Brand: John Wiley & Sons Inc
SKU: 04883795
Price: 134.09 EUR
Availability: InStock
Author: Janet Gough
ISBN: 9780470467084

Janet Gough

David Nettleton

Language

English

Book Hardback

Libristo code: 04883795

Publishers John Wiley & Sons Inc, April 2010

This book deals with a topic of critical importance for compliance with record-keeping regulations i... Full description

Libristo code: 04883795

324 b

134.09 €

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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.