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Data Integrity in Pharmaceutical and Medical Devices Regulation Operations : Best Practices Guide to

Data Integrity in Pharmaceutical and Medical Devices Regulation Operations : Best Practices Guide to - image 1 of 1

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Lopez describes good electronic records integrity practices relevant to the Worldwide Health Agency Good Manufacturing Practices. Based on risk assessment principles, he provides practical information to enable compliance with electronic records integrity while highlighting and integrating worldwide regulation into the subject. Among his topics are electronic records life cycle, electronic records related definitions, relevant worldwide good manufacturing practices regulations and guidelines, trustworthy computer systems, procedural controls for handling electronic records, electronic record controls: supporting processes, electronic record controls while in transit, electronic records and contract manufacturers, and self-inspections. Annotation ©2017 Ringgold, Inc., Portland, OR (protoview.com)
Number of Pages: 372
Genre: Medical
Format: Hardcover
Publisher: Taylor & Francis
Author: Orlando Lopez
Language: English
Street Date: October 21, 2016
TCIN: 51709361
UPC: 9781498773249
Item Number (DPCI): 248-29-3661
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$139.95
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