학술논문
Understanding and implementing a risk-based approach to 21 CFR Part 11 compliance
Document Type
Periodical
Author
Source
Pharmaceutical Technology. July 2003, Vol. 27 Issue 7, p70, 4 p.
Subject
Language
English
ISSN
1543-2521
Abstract
FDA's risk-based approach to regulatory compliance has had a significant effect on 21 CFR Part 11 requirements and the processes that pharmaceutical companies are implementing in prioritizing activities ********** As [...]