Validation of Chromatography Data Systems
Ensuring Data Integrity, Meeting Business and Regulatory Requirements
Format:Hardback
Publisher:Royal Society of Chemistry
Published:25th Nov '16
Currently unavailable, and unfortunately no date known when it will be back
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.
ISBN: 9781849736626
Dimensions: unknown
Weight: 1344g
733 pages
2nd edition