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:

• System Administrator: The System Administrator creates and maintains user accounts and user groups to specify which LHC functions, such as modifying protocols, shall be protected from use by limited-access users. The System Administrator sets special password and login characteristics including minimum password length, password aging, and idle session time-out. The System Administrator is also responsible for managing the database, LHC protocol files and audit trails.
• Support for Multiple Users: Each user is identified by a unique combination of User ID and encrypted password. Users must log in to LHC Secure with these identifiers to gain access.
• Time-Stamped Audit Trails: Activities such as user login/logout, protocol creation and modification, and plate washing are permanently logged in a secure database.
• Embedded Signatures: Authorized users can electronically sign audit trails. Electronic signatures are permanent and remain a part of the data record for the life of that file. 
• Secure Record Storage: LHC proprietary files (.lhc) are encrypted and embedded with an audit trail. Any changes made to the file (such as modifying a parameter, renaming, adding steps) are logged by the protocol audit trail whenever the file is saved. Change activities are restricted to administrators and Power Users. 
• Protected Functions: The System Administrator can protect a variety of functions from use by limited-access users, called Standard Users. These functions include the deletion, renaming, modification, and overwriting of various record types.