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(a)

Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination of identification code and password.
 

The eInfotree Excel module enforces uniqueness of User IDs thus ensuring that no two individuals have the same combination of identification code and password.

11.300(b)

Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging)

The Password Aging feature allows the system administrator to configure a password aging period for users.

Passwords expire at the end of this password aging period and must be revised.

Revised passwords can not be identical to the previous password. Passwords must meet minimum length requirements and must be a combination of of text and numbers.

Passwords are never displayed in a human readable form even to the system administrator. .