Validation of Chromatography Data Systems : Ensuring Data Integrity, Meeting Business and Regulatory Requirements

Language: English

Published by RSC Publishing Nov 2016, 2016

1849736626 / 9781849736626

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Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH

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Item description from seller

Neuware - Guiding chromatographers working in regulated industries and helping them to validate their chromatography data systems to meet data integrity, business and regulatory needs. This book is a detailed look at the life cycle and documented evidence required to ensure a system is fit for purpose throughout the lifecycle. Initially providing the regulatory, data integrity and system life cycle requirements for computerised system validation, the book then develops into a guide on planning, specifying, managing risk, configuring and testing a chromatography data system before release. This is followed by operational aspects such as training, integration and IT support and finally retirement. All areas are discussed in detail with case studies and practical examples provided as appropriate. The book has been carefully written and is right up to date including recently released FDA data integrity guidance. It provides detailed guidance on good practice and expands on the first edition making it an invaluable addition to a chromatographer's book shelf.

Seller Inventory # 9781849736626

Title
Validation of Chromatography Data Systems : Ensuring Data Integrity, Meeting Business and Regulatory Requirements
Author
Robert D McDowall
Publisher
RSC Publishing Nov 2016
Publication year
2016
Condition
Neu
Binding
Buch
Language
English
ISBN 10
1849736626
ISBN 13
9781849736626
Edition
2nd Edition
Item weight
1,251 grams
Dimensions
244x159x48 mm

AHA-BUCH GmbH

Einbeck, Germany

5-star seller

AbeBooks seller since August 14, 2006

Shipping rates from Germany to U.S.A.

Item7 to 10 business days5 to 7 business days
First itemUS$ 45.60US$ 52.85
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