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Book synopsis

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.

Book details

Book category Books in English Medicine Medicine: general issues Health systems & services

• Full title: Managing the Documentation Maze
• Author: Janet Gough, David Nettleton
• Language: English
• Binding: Hardback
• Number of pages: 488
• EAN: 9780470467084
• ISBN: 0470467088
• ID: 04883795
• Publisher: John Wiley & Sons Inc
• Weight: 806 g
• Dimensions: 241 × 168 × 30 mm
• Date of publishing: 16. April 2010

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