Managing the documentation maze answers to questions you didn't even know to ask
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 appro...
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Format: | eBook |
Language: | English |
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Hoboken, N.J.
Wiley
2010
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Collection: | O'Reilly - Collection details see MPG.ReNa |
Summary: | 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 syste |
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Physical Description: | ix, 474 pages illustrations |
ISBN: | 9781282549906 1282549901 9780470597507 0470467088 9786612549908 0470597496 9780470597491 047059750X 9780470467084 |