Does Your QMS Comply with 21 CFR Part 11?

21 CFR Part 11 is more than a regulation, it’s a framework for proving that your business runs on accurate, authentic, and trustworthy electronic records and signatures. For organizations in regulated industries, compliance ensures that digital processes are just as reliable and secure as traditional paper records and handwritten signatures.

But here’s the challenge: not every Quality Management System (QMS) meets the requirements. If your system can’t guarantee data integrity, audit trails, and controlled access, you may already be at risk of falling short of Part 11 compliance. That risk can translate into costly audits, regulatory penalties, and damaged trust with customers and regulators alike.

In this white paper, you’ll learn what 21 CFR Part 11 really requires, the common pitfalls organizations face, and how to evaluate whether your current QMS is truly compliant. You’ll also see how modern, AI-powered QMS solutions can simplify compliance while strengthening quality processes across your organization.

Download the white paper to discover how to close compliance gaps, reduce risk, and build confidence in your digital quality systems.