Books
One of the nation's foremost experts on CSV for 21 CFR Part 11, David Nettleton has written five books with Janet Gough:
NEW for 2020!
Software as a Service
Risk-Based Validation with Time-Saving Templates
(Davis Horwood International and PDA)
Co-Authored with Janet Gough
From this book, you will learn a systematic, step-by-step approach for validating configurable off-the-shelf software that generates data or controls information about products and processes subject to regulations. You will also get access to templates the authors have used as training tools for more than 1,000 companies and components of more than 300 validation projects. These tools and knowledge will assist you in establishing a compliant, timely, and successful program.
Risk-Based Software Validation
Ten Easy Steps
(Davis Horwood International and PDA)
Co-Authored with Janet Gough
(Out of Print/Stock)
Managing the Documentation Maze
(Wiley)
Co-Authored with Janet Gough
Electronic Record Keeping
Achieving and Maintaining Compliance with
21 CFR Part 11 and 45 CFR Parts 160, 162, and 164
(Interpharm/CRC)
Co-Authored with Janet Gough
Commercial Off-the-Shelf (COTS) Software Validation
for 21 CFR Part 11 Compliance.
(Davis Horwood International and PDA)
Co-Authored with Janet Gough
(Out of Print/Stock)