Under 21 CFR Part 11 Section 11.10, which of the following is required for systems that maintain closed electronic records?

Choices

1. A. Biometric identification for all users
2. B. Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records
3. C. Paper backup copies of all electronic records
4. D. Annual recertification of all electronic signatures