
|Articles|June 1, 2005
- Pharmaceutical Technology-06-01-2005
- Volume 205 Supplement
- Issue 3
The Part 11 Controversy: A Root Cause Analysis and Science-Based Solutions
The confusion surrounding the application of 21 CFR Part 11 can be solved by focusing on the common rationale that both protects the public health and drives the fundamental basis of the industry's business: good science.
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Articles in this issue
about 21 years ago
Electronic Records Management Practices and Part 11about 21 years ago
Applying Part 11 to the Implementation of Quality Management Softwareabout 21 years ago
Glossary of termsabout 21 years ago
Electronic Records Management Practices and Part 11Tamar M. Juneabout 21 years ago
21 CFR 11 Overview of the Final Document and its New Scope Ludwig HuberAdvertisement
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