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

Format Post in Computer BY Orlando Lopez

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21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry Orlando Lopez is available to download

21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry Orlando Lopez
Type:	eBook
Released:	2004
Publisher:	Informa Healthcare
Page Count:	287
Format:	pdf
Language:	English
ISBN-10:	084932243X
ISBN-13:	9780849322433

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.21 CFR 11: Complete ... Textbook 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.