Validation of Computerized Analytical Systems. Cet article n’est pas disponible.
Langue : anglais
Edité par CRC Press LLC, 1995
- Éd. originale
- Livre relié
- Occasion
Vendeur : Better World Books: West, Reno, NV, Etats-UnisBetter World Books: West
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A propos de cet article
Pages intact with minimal writing/highlighting. The binding may be loose and creased. Dust jackets/supplements are not included. Stock photo provided. Product includes identifying sticker. Better World Books: Buy Books. Do Good.
N° de réf. du vendeur 17758403-6
- Titre
- Validation of Computerized Analytical Systems
- Auteur
- Huber, Ludwig
- Éditeur
- CRC Press LLC
- Année de publication
- 1995
- État de l'article
- Good
- Reliure
- Couverture rigide
- Langue
- anglais
- ISBN à 10 chiffres
- 0935184759
- ISBN à 13 chiffres
- 9780935184754
- Édition
- 1st Edition.
- Poids de l'article
- 1,442 livre
- Dimensions
- N/A
Validation of Computerized Analytical and Networked Systems provides the definitive rationales, logic, and methodology for validation of computerized analytical systems. Whether you are involved with formulation or analytical development laboratories, chemical or microbiological quality control laboratories, LIMS installations, or any aspect of robotic in a healthcare laboratory, this book furnishes complete validation details.
International and FDA regulations and requirements are discussed and juxtaposed with numerous practical examples that show you how to cost-effectively and efficiently accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards. The templates included provide documentation examples and the many checklists found throughout the book assure that all aspects of covered in a logical sequence. The chapters describe and explain such topics as the Product Life Cycle revalidation, change control, documentation requirements, qualifications, testing, data validation and traceability, inspection, SOPs, and many other that help streamline the validation process.
International and FDA regulations and requirements are discussed and juxtaposed with numerous practical examples that show you how to cost-effectively and efficiently accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards. The templates included provide documentation examples and the many checklists found throughout the book assure that all aspects of covered in a logical sequence. The chapters describe and explain such topics as the Product Life Cycle revalidation, change control, documentation requirements, qualifications, testing, data validation and traceability, inspection, SOPs, and many other that help streamline the validation process.
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À propos de l’auteur
Huber, Ludwig
« A propos de ce titre » peut appartenir à une autre édition de cet ouvrage.
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