eInfotree Electronic Document Management System 21 CFR Part 11 Compliance

21 CFR 11 Sn.

21 CFR 11 Text

eInfotree
Compliance

eInfotree Implementation

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 system provides elaborate security controls and a comprehensive audit trail and e-signature system to ensure the authenticity, integrity and confidentiality of electronic records, and to irrevocably link an electronic signature to its owner.

authenticity - since only authorized users can create any content or electronic record in eInfotree, the authenticity of the record is assured.

integrity - changes to electronic records can only be made by authorized users. Further, all changes are recorded in a comprehensive audit trail that includes a complete copy of the previous and new record. This assures record integrity.

confidentiality - Users can be restricted from even viewing any eInfotree object or its attributes thus assuring confidentiality of the electronic record.

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

11.10(a)

Validation of systems to ensure accuracy, reliability, consistent intended performance, and  the ability to discern invalid or altered records

eInfotree has been developed following FDA recommended software development practices and procedures and is provided with validation documentation including functional requirements, software design specifications, test plan, test procedures and summary results.

Invalid records are detected at source using a comprehensive set of validation rules for data entry, and an error message is displayed to the user. Only valid records can be entered into the system. Altered records are recorded in a secure, computer-generated audit trail. Refer to Section 11.10(e) for more details on audit trail.