Understanding 21 CFR Part 11 Guidelines for Temperature Records
Instructor
Adam Hartmann Kruckow
Instructor
Jakob Konradsen
Course Overview
Gain insights into the different aspects of FDA 21 CFR Part 11 compliance and the necessary steps to maintaining temperature records that live up to the standard.
Key takeaways:
✅ Which of your records fall under 21 CFR Part 11?
✅ What security measures do you need to implement to be compliant?
✅ What should a 21 CFR Part 11 compliant audit trail include?
What You'll Learn?
- What is 21 CFR Part 11 all about?
- Which records fall under 21 CFR Part 11?
- What are the 21 CFR Part 11 requirements (for audit trails, security, and more)?
- A practical example of Part 11-compliant use in monitoring software