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

11.200(a)(1)(ii)

When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components.
 

Both User ID and password are required for signatures not executed during a single, continuous period of access.

11.200(a)(2)

Be used only by their genuine owners; and

Each User ID and password combination is created for the sole use of the genuine owner.
 

11.200(a)(3)

Be administered and executed to ensure that attempted use of an individual's electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals.
 

The protection of electronic signature components (User IDs and passwords) in combination with system controls ensures that electronic signatures cannot be falsified. System controls are described in Section 11.300.

11.200(b)

Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners.
 

Not Applicable

The eInfotree Excel Module does not use biometrics.

11.300 - Controls for identification codes/passwords.

11.300

Persons who use electronic signatures based upon use of identification codes in combination with passwords shall employ controls to ensure their security and integrity. Such controls shall include:

Refer Sections 11.300(a) to 11.300(e) below.