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

Name: Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements
SKU: GC-0289406720
Availability: InStock

$190.00

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. Additional ISBNs 1782629807, 9781782629801Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements 2nd Edition is written by Robert Mc Dowall and published by Royal Society of Chemistry. ISBNs for Validation of Chromatography Data Systems are 9781782624073, 1782624074 and the print ISBNs are 9781849736626, 1849736626. Additional ISBNs include 1782629807, 9781782629801.

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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. Additional ISBNs 1782629807, 9781782629801Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements 2nd Edition is written by Robert Mc Dowall and published by Royal Society of Chemistry. ISBNs for Validation of Chromatography Data Systems are 9781782624073, 1782624074 and the print ISBNs are 9781849736626, 1849736626. Additional ISBNs include 1782629807, 9781782629801.