FDA's 21 CFR Part 11

This is a description of the FDA's electronic-records submission requirements and how they are satisfied by LHC Secure.

A significant component of this secure software environment is the ability to create individual user accounts to ensure that only authorized users can gain access to the system and to any restricted functions. A site-designated System Administrator creates and maintains the user accounts.

LHC Secure complies with FDA's Electronic Records rule, 21 CFR Part 11: