21 CFR Part 11 - Compliance for Electronic Records and Signatures
FDA-regulated companies want electronic records for cost and efficiency, while the FDA wants to make sure those records cannot be compromised in ways that could harm patients. 21 CFR Part 11 addresses both data security and patient safety.
This 60-minute 21 CFR Part 11 compliance webinar explains what the regulation is, why it matters, and how Part 11 conformance differs from simply having good IT security. You'll learn the procedures for controlling electronic records and signatures described in FDA guidance.
The session also covers the FDA's validation requirements, which have both technical and procedural parts, and explains open, closed and hybrid paper-and-electronic systems.
- Explain what 21 CFR Part 11 is and why it matters
- Distinguish Part 11 conformance from general IT security
- Describe the FDA's selective enforcement approach
- Apply controls for electronic records and electronic signatures
- Classify open, closed and hybrid systems
- Plan Part 11 validation using risk analysis
- Origin of the regulation and changes in interpretation
- Electronic records
- Electronic signatures
- Data security
- Open, closed and hybrid systems
- Validation methods
- Risk analysis
Much of the worry around Part 11 comes from confusion. The FDA first published a strict version of the rule, then, after industry objected that no one would move to electronic records, chose to "selectively enforce" parts of it rather than rewrite it. This webinar explains what that means in practice.
It is aimed at engineering, QA, IT and management staff in FDA-regulated companies.
- Engineering Personnel
- QA
- IT
- Management
Edwin Waldbusser, is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.
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