Products
 
Microsoft Gold Certified Partner
 

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

Subpart B – Electronic Records

Sec. 11.10 Controls for closed systems

11.10

Employ controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following:

The eInfotree Excel Module provides security controls, audit trail and e-signature functionality to ensure the authenticity, integrity and confidentiality of electronic records, and to irrevocably link an electronic signature to its owner. Since only authorized users can create any content or electronic record in the eInfotree Excel Module, the authenticity of the record is assured. Further, changes to electronic records can only be made by authorized users. Further, all changes are recorded in an audit trail that includes the old value and the new value. This assures record integrity.

Refer to Sections 11.10(a) to 11.10(k) for more details.

© Copyright 2000-2010. CIMCON Software, Inc. All rights reserved.