FDA Regulatory Reference from C.H.I.P.S.

Complete Guide
to International Computer Validation Compliance for the Pharmaceutical Industry

by Orlando Lopez

  • Covers computer systems qualification, inspections and testing, and sample qualification by GAMP types of software
  • Shows how to maintain the state of the validation after the system has been released for operation
  • Explains how technologies such as hashing, encryption, and digital signature can support Part 11
  • Includes coverage change management and control, training, and security followed by guidance on source code issues and suppliers' qualifications

Covering regulatory requirements stipulated by FDA and GAMP guidelines, Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance. Whether you need to validate computer systems for pharmaceutical cosmetic, food, or medical devise applications, this book is indispensable.

Discussing the regulatory requirements that are the foundation for any project, the book introduces a model that can be used to determine the Part 11 requirements for consideration during implementation. The book establishes a top-down approach to the integration of computer systems validation strategies in support of a computer systems validation project. It focuses on practical issues in computer systems implementation and operational life project management, including relevant activities to comply with Part 11, validation planning, and scheduling. The book reviews documentation in relation to CSV and procedural controls in regulated operations.

Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry shows how to enable compliance with computer systems validation requirements while highlighting and integrating Part 11 requirements into the entire computer validation program. The author places regulatory compliance within the context of quality assurance and emphasizes the importance of integrating validation into the system lifecycle using a structured top-down approach. This systematic approach helps you efficiently develop compliant software and maintenance its compliance.


  • Introduction

  • Validation Overview
    • What is a Computer System?
    • What is a Computer System Validation?
    • Why Do We Validate Computer Systems?
    • Key Project Elements
    • Which Systems Should be Validated?
    • Introduction to Computer Systems Validation Process
    • Computer Systems Validation for Low Criticality and/or Low Complexity Projects

  • USA Regulatory Requirements for Computer Systems
    • Medical Device Software
    • The Food Industry

  • New Computer Systems Validation Model

  • Computer Validation Management Cycle

  • Computer Validation Program Organization
    • Organizational Model
    • CSV Executive Committee
    • CSV Cross-Functional Team
    • Computer Systems Validation Groups and Teams
    • Management Group
    • Validation Program Coordinators

  • The Computer Systems Validation Process

  • Validation Project Plans and Schedules
    • Regulatory Guidance
    • Validation Project Plans
    • Mandatory Signatures
    • Project Schedule

  • Inspections and Testing
    • Regulatory Guidance
    • Introduction
    • Document Inspections and Technical Reviews
    • White Box Testing
    • Black Box Testing
    • Other Testing Types

  • Qualifications
    • Hardware Installation Qualification
    • Software Installation Qualification
    • System Operational Qualification
    • System Performance Qualification
    • Operating System and Utility Software Installation Verification
    • Standard Instruments, Microcontrollers, Smart Instrumentation Verification
    • Standard Software Packages Qualification
    • Configurable Software Qualification
    • Custom-Built Systems Qualification

  • SLC Documentation
    • Regulatory Guidance
    • SLC Documentation

  • Relevant Procedural Controls

  • Change Management
    • Introduction
    • Change Management Process

  • Training
    • Regulatory Guidance
    • Training in the Regulated Industry

  • Security
    • Regulatory Guidance
    • Introduction
    • Physical Security
    • Network Security
    • Applications Security
    • Other Key Security Elements

  • Source Code
    • Regulatory Guidance

  • All Together
    • Acquisition Process
    • Supply Process
    • Development Process
    • Operation Process
    • Maintenance Process

  • The Future

Appendix A: Glossary of Terms
Appendix B: Abbreviations
Appendix C: Applicability of New Computer Validation Model
Appendix D: Criticality and Complexity Assessment
Appendix E: Sample Development Activities by Periods
Appendix F: Administrative Procedures Mappe to Part 11
Appendix G: Sample Audit Checklist for a Closed System
Appendix H: Computer Systems Regulatory Requirements
Appendix I: Technical Design Key Practices

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Complete Guide to International
Computer Validation Compliance
for the Pharmaceutical Industry

by Orlando Lopez
264 pages $228.95 + shipping
Texas residents please add 6.75 % sales tax

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