User Qualifications - 11.10 (i)
- Last UpdatedFeb 12, 2025
- 1 minute read
21 CFR Part 11:
“(i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.”
The method or methods used to determine persons who are qualified to interact with ER/ES systems must be defined.