RSC Chromatography Monographs: Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements (Hardcover)

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.