Description: Validation of Chromatography Data Systems : Ensuring Data Integrity, Meeting Business and Regulatory Requirements, Hardcover by Mcdowall, Robert; Smith, Roger (EDT), ISBN 1849736626, ISBN-13 9781849736626, Like New Used, Free shipping in the US
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, th 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.
Th 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.
Guiding chromatographers working in regulated industries and helping to validate their chromatography data systems to meet both business and regulatory needs, this book will be a detailed look at the requirements to ensure a system is fit for purpose throughout the life cycle. The work is divided into four parts, initially providing a background to the regulatory requirements and documented evidence needed to support a claim that a system is validated. Development of the system, operation and finally retirement are then all discussed in detail with case studies and practical examples provided as appropriate.Price: 269.25 USD
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Book Title: Validation of Chromatography Data Systems : Ensuring Data Integri
Item Length: 9.2in
Item Width: 6.1in
Author: Robert Mcdowall
Publication Name: Validation of Chromatography Data Systems : Ensuring Data Integrity, Meeting Business and Regulatory Requirements
Format: Hardcover
Language: English
Features: New Edition
Publisher: Royal Society of Real Chemistry, T.H.E.
Publication Year: 2016
Series: Issn Ser.
Type: Textbook
Item Weight: 47.4 Oz
Number of Pages: 733 Pages
