21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
Author:   Orlando López
Publisher:   Taylor & Francis Inc
ISBN:  

9780849322433


Pages:   260
Publication Date:   15 January 2004
Format:   Hardback
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

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


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Full Product Details

Author:   Orlando López
Publisher:   Taylor & Francis Inc
Imprint:   CRC Press Inc
Dimensions:   Width: 17.80cm , Height: 2.00cm , Length: 25.40cm
Weight:   0.612kg
ISBN:  

9780849322433


ISBN 10:   084932243
Pages:   260
Publication Date:   15 January 2004
Audience:   General/trade ,  General
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

Table of Contents

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance. The author introduces appropriate 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. The material is presented through 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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López, Orlando

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