Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements (RSC Chromatography Monographs, Volume 20)
Language: English
Published by Royal Society of Chemistry, 2016
- Hardcover
- New
Seller: Ria Christie Collections, Uxbridge, United KingdomRia Christie Collections
AbeBooks seller since March 25, 2015
Condition: New
US$ 320.70
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In English.
Seller Inventory # ria9781849736626_new
- Title
- Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements (RSC Chromatography Monographs, Volume 20)
- Author
- McDowall, Robert D
- Publisher
- Royal Society of Chemistry
- Publication year
- 2016
- Condition
- New
- Binding
- Hardcover
- Language
- English
- ISBN 10
- 1849736626
- ISBN 13
- 9781849736626
- Edition
- 2nd Edition
- Item weight
- 1,462 grams
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.
"Synopsis" may belong to another edition of this title.
From the Back Cover
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.
"About the title" may belong to another edition of this title.
Ria Christie Collections
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AbeBooks seller since March 25, 2015
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