Validation of Computerized Analytical Systems. Dieser Artikel ist nicht verfügbar.
Sprache: Englisch
Verlag: CRC Press LLC, 1995
- Erstausgabe
- Hardcover
- Gebraucht
Anbieter: Better World Books: West, Reno, NV, USABetter World Books: West
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Artikelbeschreibung des Verkäufers
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.
Bestandsnummer des Verkäufers 17758403-6
- Titel
- Validation of Computerized Analytical Systems
- Autor
- Huber, Ludwig
- Verlag
- CRC Press LLC
- Erscheinungsjahr
- 1995
- Zustand
- Good
- Einband
- Hardcover
- Sprache
- Englisch
- ISBN-10
- 0935184759
- ISBN-13
- 9780935184754
- Auflage
- 1st Edition.
- Artikelgewicht
- 1,442 Pfund
- Abmessungen
- 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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Über die Autorin bzw. den Autor
Huber, Ludwig
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