21 CFR Part 11

The 21 CFR Part 11 compliance standard set forth by the FDA for the purpose of governing electronic documents and signatures is a simple guideline with numerous implications on health research and care organizations. Personam had two direct fits and three indirect feature fits for the compliance standard.

Key Finding(s)

1. Personam fits a direct requirement where the organization must flag any activity that is not per the normal work flow on the network