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###-Book Description Begin-###
by Orlando Lopez (Author)
Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement. Compliance is a state of being in accordance with established guidelines or specifications.
This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems are correctly achieved.
Hardcover: 344 pages
Publisher: Productivity Press; 1 edition (September 19, 2018)
Language: English
ISBN-10: 9781138041189
ISBN-13: 978-1138041189
