21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry - Tapa blanda

López, Orlando

 
9780367394592: 21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
Tapa blanda
ISBN 10: 0367394596 ISBN 13: 9780367394592
Editorial: CRC Press, 2019

Sinopsis

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.

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Acerca del autor

López, Orlando

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Editorial
CRC Press
Año de publicación
2019
Idioma
Inglés
ISBN 10 
0367394596
ISBN 13 
9780367394592
Encuadernación
Tapa blanda
Número de edición
1
Número de páginas
260
Contacto del fabricante
Taylor and Francis, GPSR Taylor and Francis
gpsr@taylorandfrancis.com

Taylor & Francis Verlag GmbH, Kaufingerstraße 24
München
80331
Alemania

Otras ediciones populares con el mismo título

9780849322433: 21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

Edición Destacada

ISBN 10:  084932243X ISBN 13:  9780849322433
Editorial: CRC Press, 2004
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