O ovoj e-knjizi
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.
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 thro...
Saznajte više
Ocijenite ovu e-knjigu
Recite nam što mislite.
Informacije o čitanju
Pametni telefoni i tableti
Instalirajte aplikaciju Google Play knjige za Android i iPad/iPhone. Automatski se sinkronizira s vašim računom i omogućuje vam da čitate online ili offline gdje god bili.
Prijenosna i stolna računala
Audioknjige kupljene na Google Playu možete slušati pomoću web-preglednika na računalu.
Elektronički čitači i ostali uređaji
Za čitanje na uređajima s elektroničkom tintom, kao što su Kobo e-čitači, trebate preuzeti datoteku i prenijeti je na svoj uređaj. Slijedite detaljne upute u centru za pomoć za prijenos datoteka na podržane e-čitače.
