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When regulators come knocking: 21 CFR Part 11 compliance overview
Compliance DeepDive
23 minutes 32 seconds
5 months ago
When regulators come knocking: 21 CFR Part 11 compliance overview
Dive into the essentials of 21 CFR Part 11 in this episode of Compliance DeepDive. Learn how to ensure your electronic records and signatures meet FDA standards. We unpack common compliance gaps—like audit trails, access controls, training, and backup systems—and offer insights to help your pharma operations stay inspection-ready. Listen now to strengthen your compliance strategy.