Part 11 Requirements Still Important, Industry Experts Warn

Drug GMP Report
KEYWORDS Part 11 / Technology

The FDA has not lost interest in electronic data integrity, audit trails or computer system validation, even though it has stated it will exercise enforcement discretion regarding 21 CFR Part 11, experts stressed at FDAnews’ recent FDA Information Management Summit in Bethesda, Md.

To View This Article:


Subscribe To Drug GMP Report

Buy This Article Now

Add this article to your cart for $10.00