Managing the Documentation Maze: Answers to Questions You Didn't Even Know to Ask - Hardcover

"Managing the Document Maze takes a fascinating and extremely effective approach to its topic ... this organisational framework makes it very easy to target information that will answer specific questions of interest to the reader, while also providing a comprehensive overview of key information ...Managing the Document Maze is recommended to readers, and receives the JCS Library Award." (Journal for Clinical Studies, 1 July 2010)

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.