21 CFR Part 11 Compliance Checklist for EDC Systems
21 CFR Part 11 Compliance Checklist for EDC Systems
A step-by-step checklist to ensure your electronic data capture system meets FDA requirements for electronic records and signatures.
Checklist 12 pages Regulatory
What's Inside
- 1Section 1: Understanding 21 CFR Part 11 scope and applicability
- 2Section 2: Electronic records — audit trails, copies, and retention
- 3Section 3: Electronic signatures — uniqueness, verification, and binding
- 4Section 4: System validation and access controls
- 5Section 5: Practical compliance assessment for your EDC system
Key Takeaways
Compliance Clarity
Demystify FDA requirements with plain-language explanations of each Part 11 subpart.
Audit-Ready Checklist
A printable checklist your QA team can use during vendor qualification audits.
Gap Analysis Template
Identify exactly where your current EDC system falls short of Part 11 requirements.
Risk-Based Approach
Learn how to apply risk-based thinking to prioritize remediation efforts.