Medical device companies want electronic records for efficiency, while FDA wants to keep those records from being compromised in ways that could harm patients. 21 CFR Part 11 addresses both data security and patient safety.
This 90-minute webinar explains what Part 11 is, why it matters, and how conformance differs from simply having good IT security. You'll learn the procedures for controlling electronic records and signatures described in FDA guidance, and the technical and procedural requirements for Part 11 validation.
The session also explains the origin of the regulation, the confusion around FDA's "selective enforcement", and how open, closed and hybrid paper-electronic systems differ, along with risk analysis.
WHY SHOULD YOU ATTEND?
Many companies hesitate to move to electronic records for fear of weakening their quality system and receiving 483s. Much of that fear comes from confusion about how FDA enforces Part 11.
This session clears it up for engineering, QA, IT and management staff at medical device companies.
AREA COVERED
- Origin of the regulation and changes in interpretation
- Selective enforcement explained
- Electronic records
- Electronic signatures
- Part 11 vs general data security
- Open, closed and hybrid systems
- Validation methods
- Risk analysis
LEARNING OBJECTIVES
- Explain what 21 CFR Part 11 is and why it matters
- Distinguish Part 11 conformance from general IT security
- Apply FDA procedures for controlling electronic records and signatures
- Describe FDA's selective enforcement approach
- Classify open, closed and hybrid systems
- Plan Part 11 validation with risk analysis
WHO WILL BENEFIT?
- Engineering personnel
- QA
- IT
- Management
Many companies hesitate to move to electronic records for fear of weakening their quality system and receiving 483s. Much of that fear comes from confusion about how FDA enforces Part 11.
This session clears it up for engineering, QA, IT and management staff at medical device companies.
- Origin of the regulation and changes in interpretation
- Selective enforcement explained
- Electronic records
- Electronic signatures
- Part 11 vs general data security
- Open, closed and hybrid systems
- Validation methods
- Risk analysis
- Explain what 21 CFR Part 11 is and why it matters
- Distinguish Part 11 conformance from general IT security
- Apply FDA procedures for controlling electronic records and signatures
- Describe FDA's selective enforcement approach
- Classify open, closed and hybrid systems
- Plan Part 11 validation with risk analysis
- Engineering personnel
- QA
- IT
- Management