eInfotree Excel Plug-In 21 CFR Part 11 Compliance

21 CFR 11 Sn.

21 CFR 11 Text

eInfotree
Excel Module
Compliance

eInfotree Excel Module
Implementation

Client Responsibilities

11.300(c)

Following loss management procedures to electronically deauthorize lost, stolen, missing, or otherwise potentially compromised tokens, cards, and other devices that bear or generate identification code or password information, and to issue temporary or permanent replacements using suitable, rigorous controls.
 

The eInfotree Excel Module administrator has authority to disable user accounts and to reset passwords. Users are required to modify their passwords immediately on first login or following a password reset.

11.300(d)

Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner any attempts at their unauthorized use to the system security unit, and, as appropriate, to organizational management.

The system administrator can configure the maximum number of invalid login attempts before the user account is automatically disabled.

All security related events such as login, logout, account lockout, password change, and unlocking of account are logged into a security audit trail.

The system administrator can query the security audit trail using a Graphical Query Builder with filters based on User ID, Event and Date Ranges.

Knowledge of a person's unavailability can be used by the system administrator to disable user accounts for specific time-periods.