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

Boca Raton: CRC Press LLC. – 2004. – 286 p. This book speaks to all those involved in planning and undertaking computer systems validation in the United States of America’s Food and Drug Administration (FDA) regulated industries, mainly pharmaceuticals. The topics and discussion levels reflect what I believe such people will find interesting or useful. My vision for this book is that it reveals my perspective on how to perform computer systems validation, and gives my readers a clear picture on how they must work effectively in a quality role in today’s high-pressure, regulated environment. Focusing on project management, I have chosen to include materials not normally stressed in a computer systems book applicable to the FDA regulated industries. Estimating, planning, and scheduling computer systems validation are hard to pin down, because there is no true end to a project. More verification and testing are always required, and there are serious risks associated with skipping them. Project managers must be fully aware of these ‘trade-offs,’ and need to share this knowledge with their teams. Efficiency is a major concern in this book.Foreword.Publisher’s Note.
Dedication.Validation Overview.
USA Regulatory Requirements for Computer Systems.
New Computer Systems Validation Model.
Computer Validation Management Cycle.
Computer Validation Program Organization.
The Computer Systems Validation Process.
Validation Project Plans and Schedules.
Inspections and Testing.
Qualifications.
SLC Documentation.
Relevant Procedural Controls.
Change Management.
Training.
Security.
Source Code.
Hardware/Software Suppliers Qualification.
Maintaining the State of Validation.
Part 11 Remediation Project.
Operational Checks.
Compliance Policy Guide (CPG) 7153.17.
Electronic Records.
Electronic Signatures.
Technologies Supporting Part 11.
All Together.
The Future.
Glossary of Terms.
Abbreviations and Acronyms 1.
Applicability of a Computer Validation Model.
Criticality and Complexity Assessment.
Sample Development Activities Grouped by Project Periods.
Administrative Procedures Mapped to Part 11.
Sample Audit Checklist for a Closed System.
Computer Systems Regulatory Requirements.
Technical Design Key Practices.