Docket Management
Docket: 00D-1538 - Draft Guidance for Industry; Electronic Records; Electronic Signatures, Validation
Comment Number: EC -8

Accepted - Volume 6

Comment Record
Commentor Dr. Ludwig Huber Date/Time 2001-12-23 18:33:48
Organization Agilent
Category Individual

Comments for FDA General
Questions
1. General Comments I recommend to add under General Quality References the Book: Huber L, Validation of Computerized Analytical and Networked Systems, Interpharm Press, Englewood, Co, 2002, ISBN 1-57491-133-3 This is the second edition of the current reference book for validating computer systems in pharmaceutical laboratories from the same author: Validation of Computerized Analytical Systems




EC -8