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

11.10(i)

Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.
 

CSI personnel involved with developing and maintaining the eInfotree Excel Module have the required combination of education, training and experience to perform their assigned tasks.

Client shall establish SOPs to comply with this Procedural Control. CSI can provide training to client trainers or end-users to help comply with this requirement.

11.10(j)

The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification.
 

Not Applicable

Client Procedural Control.

Client shall establish SOPs to comply with this Procedural Control.

11.10(k)
11.10(k)(1)

Use of appropriate controls over systems documentation including:

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

CSI has established internal procedures to provide adequate controls over the distribution and release of CSI documentation for system operation and maintenance.

Client SOPs shall establish adequate control over CSI or client-developed onsite documentation.

11.10(k)(2)

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

CSI has established revision and change control procedures that provides a time-sequenced revision history relating to the development and modification of CSI systems documentation.

Client SOPs shall establish adequate control over CSI or client-developed onsite systems documentation as applicable.

11.30

Controls for open systems.

Not Applicable

The eInfotree Excel Module is considered to be a closed system.