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Aprašymas

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.