Description
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
Physical Description:ix, 474 pages illustrations
ISBN:9781282549906
1282549901
9780470597507
0470467088
9786612549908
0470597496
9780470597491
047059750X
9780470467084