Pharmaceutical Computer Systems Validation : Quality Assurance, Risk Management and Regulatory Compliance.

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Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements fo...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Wingate, Guy
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Hoboken : CRC Press, 2010.
Edición:2nd ed.
Temas:
Pharmaceutical industry > Management.
Pharmaceutical industry > Data processing.
Health facilities > Risk management.
Risk management > Data processing.
Industrie pharmaceutique > Gestion.
Industrie pharmaceutique > Informatique.
Équipements sanitaires > Gestion du risque.
Gestion du risque > Informatique.
MEDICAL > Pharmacology.
Health facilities > Risk management
Pharmaceutical industry > Data processing
Pharmaceutical industry > Management
Risk management > Data processing
Acceso en línea:Texto completo
Descripción
Sumario:Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm w.
Descripción Física:1 online resource (773 pages)
ISBN:9781420088953
1420088955

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