Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation

Language: English

Published by Productivity Press Jun 2021, 2021

1032094702 / 9781032094700

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Seller: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, GermanyBuchWeltWeit Ludwig Meier e.K.

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Softcover

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This item is printed on demand - it takes 3-4 days longer - Neuware -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 (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority's requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions.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 is correctly achieved. 344 pp. Englisch.…

Seller Inventory # 9781032094700

Title
Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation
Author
Orlando Lopez
Publisher
Productivity Press Jun 2021
Publication year
2021
Condition
Neu
Binding
Taschenbuch
Language
English
ISBN 10
1032094702
ISBN 13
9781032094700
Item weight
648 grams
Dimensions
254x178x19 mm

BuchWeltWeit Ludwig Meier e.K.

Bergisch Gladbach, Germany

5-star seller

AbeBooks seller since January 11, 2012

Shipping rates from Germany to U.S.A.

Item5 to 15 business days5 to 15 business days
First itemUS$ 25.89US$ 25.89
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BuchWeltWeit Ludwig Meier e.K.

Germany