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

López, Orlando

Hardcover

ISBN 10: 084932243X ISBN 13: 9780849322433

Verlag: CRC Press, 2004

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Reseña del editor:

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.

Über diese Auflage

• Verlag: CRC Press
• Erscheinungsdatum: 2004
• ISBN 10: 084932243X
• ISBN 13: 9780849322433
• Einband: Tapa dura
• Auflage: 1
• Anzahl der Seiten: 260