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.
Betal nemt med kort, Klarna, Apple Pay eller Google Pay. Ikke tilfreds? Du har altid 14 dages fortrydelsesret. Læs mere i vores vilkår. Har du spørgsmål, så send os en mail på hello@memmo.org.
Memmo gør det nemmere at studere – uanset hvor du er i verden. Hos os samler du dine kursusbøger og smarte studieværktøjer ét sted: resuméer, quizzer, podcasts og flashcards. Og så er der Ted, din studieven, der svarer på alt, du undrer dig over. Over 50 000 studerende studerer allerede her – bygget til at hjælpe dig med at lære hurtigere og stresse mindre.