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

11.50(b)

The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls as for electronic records, and shall be included as part of any human readable form of the electronic record (such as electronic display or printout).
 

Stored in the Excel file along with Excel data, e-signature components are subject to the same controls as the electronic records, and can be included in any human readable form of the electronic record.

11.70 Signature/record linking.

11.70

Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.
 

Once executed, the e-signature is irrevocably linked to the electronic record and cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.

11.100 General requirements.

11.100(a)

Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.

eInfotree Excel Module enforces the uniqueness of each userid and password combination. This combination can not be reused or reassigned to anyone else, even after the original User ID has been deactivated or is no longer active.