Descrição
Table of Contents
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
Appendices
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
