UID:
almafu_9959328680302883
Format:
1 online resource (ix, 474 pages) :
,
illustrations
ISBN:
9780470597507
,
047059750X
,
9780470597491
,
0470597496
,
0470467088
,
9780470467084
,
1282549901
,
9781282549906
Content:
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.
Note:
Managing the documentation maze; contents; introduction; about the authors; chapter 1 understanding the regulations; chapter 2 people, process, and documentation; chapter 3 principles of document management; chapter 4 deciding to go electronic and finding a vendor; chapter 5 making the transition from hybrid to validated e-system; chapter 6 part 11 compliance; chapter 7 standard operating procedures; chapter 8 nonclinical records; chapter 9 clinical and submission records; chapter 10 consistency and readability in documents; chapter 11 maintaining the system.
,
Chapter 12 maintaining inspection readinesschapter 13 resources; appendix; index.
Additional Edition:
Print version: Gough, Janet. Managing the documentation maze. Hoboken, N.J. : Wiley, ©2010 ISBN 9780470467084
Additional Edition:
ISBN 0470467088
Language:
English
Keywords:
Electronic books.
;
Electronic books.
;
Electronic books.
DOI:
10.1002/9780470597507
URL:
https://onlinelibrary.wiley.com/doi/book/10.1002/9780470597507
URL:
https://onlinelibrary.wiley.com/doi/book/10.1002/9780470597507
URL:
https://onlinelibrary.wiley.com/doi/book/10.1002/9780470597507
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