eInfotree Electronic Document Management System 21 CFR Part 11 Compliance

21 CFR 11 Sn.

21 CFR 11 Text

eInfotree
Compliance

eInfotree Implementation

11.10(k)

Use of appropriate controls over systems documentation including:

Not Applicable

Procedural Control.

11.10(k)(1)

Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.
 

Not Applicable

Procedural Control.

11.10(k)(2)

Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.
 

Not Applicable

Procedural Control.

11.30

Not Applicable

eInfotree is considered a closed system.

11.50

Signature manifestations.

11.50(a)

Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:

(1)  The printed name of the signer;  

(2) The date and time when the  signature was executed; and 

(3) The meaning (such as review, approval,responsibility, or   authorship) associated with the  signature.
 

Signed electronic records in eInfotree contain the full printed name of signer, date/time when the signature was executed and meaning of signature. The system administrator can configure various roles in eInfotree such as Review, Approve, and Create. User authority for signatures can be restricted to specific roles. For example, users can be granted roles to sign with a Review role, but not with an Approve role.

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).
 

E-signature records are fully secure from unauthorized access, and can be displayed or printed for any electronic record.

11.70

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 an e-signature is applied to a database or file object, an irrevocable link is established between the esignature and the object. The esignature can not be deleted, copied or otherwise transferred to falsify the electronic record.