Sharing her 20+ years of in-depth practical experience, Dr. Stokes has created a comprehensive and detailed guide to computer validation describing practices that have been shown to successfully pass audits and inspections both in North America and Europe. The book provides a standard model for producing validation documents and formal testing practices that work for any software system or infrastructure platform. The model and practices allow systems to comply with global regulations and guidance for electronic recordkeeping and Good Clinical, Laboratory, or Manufacturing Practice laws (Part 11, GCP, GLP, GMP, Annex 11 = GXP).
The book is divided into 10 independent chapters that discuss in detail the roles and responsibilities for end user management, user teams, IT infrastructure teams, software suppliers, quality assurance and quality control personnel, electronic archivists, and corporate governance. Twenty-nine chapter appendices provide full scale examples of validation document sets, policies, and SOPs from real projects to illustrate the concepts discussed. Dr. Stokes has also compiled an extensive glossary of 80 validation-related terms to provide the reader with quick access to definitions that are understandable by non-IT professionals.
The book is written in a manner that can be read and understood by both IT and non-IT professionals. To support focused and distance learning, Dr. Stokes has made this book available in hard copy and also as electronic briefing units of specific chapters for download to PCs. Both are available at http://www.BioPharm-Guides.com. Dr. Stokes has commented that, “The practices described in this book are not the only way to perform computer validation, but they are one way that experience has shown to be workable and auditable with positive results.