21 CFR Part 11 Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry 1st Edition by Orlando Lopez ISBN 1135488754 9781135488758

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Product details:

ISBN 10: 1135488754

ISBN 13: 9781135488758

Author:  Orlando Lopez 

21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry 1st Edition: 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.

 

21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry 1st Edition Table of contents:

Chapter 1: Introduction
Chapter 2: Validation Overview
Chapter 3: USA Regulatory Requirements for Computer Systems
Chapter 4: New Computer Systems Validation Model
Chapter 5: Computer Validation Management Cycle
Chapter 6: Computer Validation Program Organization
Chapter 7: The Computer Systems Validation Process
Chapter 8: Validation Project Plans and Schedules
Chapter 9: Inspections and Testing
Chapter 10: Qualifications
Chapter 11: SLC Documentation
Chapter 12: Relevant Procedural Controls
Chapter 13: Change Management
Chapter 14: Training
Chapter 15: Security
Chapter 16: Source Code
Chapter 17: Hardware/Software Suppliers Qualification
Chapter 18: Maintaining the State of Validation
Chapter 19: Part 11 Remediation Project
Chapter 20: Operational Checks
Chapter 21: Compliance Policy Guide (CPG) 7153.17
Chapter 22: Electronic Records
Chapter 23: Electronic Signatures
Chapter 24: Technologies Supporting Part 11
Chapter 25: All Together
Chapter 26: The Future

 

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