When regulators come knocking: 21 CFR Part 11 compliance overview

Compliance DeepDive
11/06/2025 23 min Episodio 15
When regulators come knocking: 21 CFR Part 11 compliance overview

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Episode Synopsis

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.

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