FDA 21 CFR Part 11 Validation

Compliance with FDA 21 CFR Part 11 regulations requires the FDA 21 CFR Part 11 validation of a company's electronic quality management system.

Many FDA-regulated companies are saving time and money by investing in automated quality management and document control systems. These systems require FDA 21 CFR Part 11 validation (see 21 CFR Part 11 Section 11.10a.)

21 CFR Part 11 Industry Overview: Ready for an FDA Inspection?
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