21 CFR Part 11: Where Are We Now?

Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology-11-01-2003
Volume 2003 Supplement
Issue 5

FDA's revised guidance on 21 CFR Part 11 offers relief to the regulated industry by providing for enforcement discretion and suggesting a risk-based approach to compliance.

External Link - article-75135.pdf

Articles in this issue
Improving the Management of Batch Records
21 CFR Part 11: Where Are We Now?
Understanding Data, Symbol, and Technology Options
Web Services in Pharmaceutical Manufacturing
Integrated Compliance Management
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