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Item Details
Title: DATA INTEGRITY IN PHARMACEUTICAL AND MEDICAL DEVICES REGULATION OPERATIONS
BEST PRACTICES GUIDE TO ELECTRONIC RECORDS COMPLIANCE
By: Orlando Lopez
Format: Hardback

List price: £135.00
Our price: £121.50
Discount:
10% off
You save: £13.50
ISBN 10: 1498773249
ISBN 13: 9781498773249
Availability: Usually dispatched within 1-3 weeks.
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Publisher: TAYLOR & FRANCIS INC
Pub. date: 11 October, 2016
Pages: 394
Synopsis: Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years' experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.
Illustrations: 55 black & white illustrations, 11 black & white tables
Publication: US
Imprint: Productivity Press
Returns: Returnable
Some other items by this author:
21 CFR (HB)
21 CFR COMPLIANCE ASSESSMENT GUIDE (PB)
21 CFR PART 11
21 CFR PART 11
21 CFR PART 11
21 CFR PART 11
21 CFR PART 11
21 CFR PART 11
21 CFR PART 11 COMPLETE GUIDE (PB)
21 CFR PART 11 COMPLIANCE (PB)
AN EASY TO UNDERSTAND GUIDE TO 21 CFR PART 11
AN EASY TO UNDERSTAND GUIDE TO 21 CFR PART 11 (PB)
AN EASY TO UNDERSTAND GUIDE TO ANNEX 11
AN EASY TO UNDERSTAND GUIDE TO ANNEX 11 (PB)
AUTOMATED BATCH RECORD SYSTEMS (PB)
DATA INTEGRITY IN PHARMACEUTICAL AND MEDICAL DEVICES REGULATION OPERATIONS
DATA INTEGRITY IN PHARMACEUTICAL AND MEDICAL DEVICES REGULATION OPERATIONS
DATA INTEGRITY IN PHARMACEUTICAL AND MEDICAL DEVICES REGULATION OPERATIONS
DATA INTEGRITY IN PHARMACEUTICAL AND MEDICAL DEVICES REGULATION OPERATIONS
ENSURING THE INTEGRITY OF ELECTRONIC HEALTH RECORDS
ENSURING THE INTEGRITY OF ELECTRONIC HEALTH RECORDS (HB)
EU ANNEX 11 GUIDE TO COMPUTER VALIDATION COMPLIANCE FOR THE WORLDWIDE HEALTH AGENCY GMP
EU ANNEX 11 GUIDE TO COMPUTER VALIDATION COMPLIANCE FOR THE WORLDWIDE HEALTH AGENCY GMP (HB)
PHARMACEUTICAL AND MEDICAL DEVICES MANUFACTURING COMPUTER SYSTEMS VALIDATION
QUALIFICATION OF COMPUTER NETWORKS (PB)
QUALIFICATION OF SCADA SYSTEMS (PB)
REQUIREMENTS OF E-RECORDS INTEGRITY (HB)

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