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 Information
ISBN 9780470467084
Author Janet Gough
Format Hardback
Page Count 488
Imprint John Wiley & Sons Inc
Publisher John Wiley & Sons Inc
Weight(grams) 808g