A UL EduNeering course
This course will provide the learner with an understanding of how to implement Part 11 and what it means in terms of FDA’s enforcement policy for 21 CFR Part 11, Electronic Records; Electronic Signatures. The course discusses the Guidance for Industry; Part 11, Electronic Records; Electronic Signatures – Scope and Application, August 2003.
- Identify steps to prepare for an inspection
- Electronic signatures
- System documentation
- Audit trails