FDA Part 11 Compliance Checklist | Complete Guide
If your organization operates in pharmaceuticals, medical devices, biotech, or life sciences, you can’t afford to ignore FDA 21 CFR Part 11 compliance. In 2025, over 78% of FDA warning letters in pharma and clinical trials cited data integrity and Part 11 gaps – mainly missing audit trails, improper electronic signatures, and lack of validation.
This video breaks down everything you need to know about FDA 21 CFR Part 11 – from electronic records and signatures to validation, audit trails, and compliance checklists. We’ll guide you step by step so your systems remain audit-ready and your data stays secure, reliable, and FDA-compliant.
🔒 Why it matters in 2025?
The global GxP compliance software market is projected to hit $11.4 billion by 2027, with FDA Part 11 as a key driver.
Non-compliance can lead to multi-million-dollar penalties – in 2024, one pharma firm paid $190M in remediation due to data integrity failures.
With rising use of AI-driven drug discovery and cloud-based clinical trials, FDA scrutiny of electronic systems is tighter than ever.
✅ What you’ll learn in this video:
What is FDA 21 CFR Part 11 & why it matters
Key requirements for electronic records & electronic signatures
FDA’s risk-based approach to compliance
Step-by-step compliance checklist (Inventory, Gap Analysis, Validation, SOPs, Security, Monitoring)
Common mistakes companies make & how to avoid them
How to protect your business, patients, and reputation
👨💻 About Us – VISTA InfoSec
We are a global cybersecurity & compliance consulting firm with over 20 years of expertise. Trusted worldwide, we help organizations achieve FDA 21 CFR Part 11, PCI DSS, HIPAA, ISO 27001, GDPR, SWIFT CSP, and SOC 2 compliance.
📩 Need help with FDA 21 CFR Part 11 compliance? Reach us at: sales@vistainfosec.com
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📊 Timestamps:
00:00 – Intro
01:10 – Why FDA 21 CFR Part 11 Matters
03:20 – Key Requirements Explained
06:40 – FDA 21 CFR Part 11 Compliance Checklist
10:00 – Common Compliance Pitfalls
12:30 – Closing & Next Steps
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