eInfotree Electronic Document Management System 21 CFR Part 11 Compliance

21 CFR 11 Sn.

21 CFR 11 Text

eInfotree
Compliance

eInfotree Implementation

11.10(b)

The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records.
 

eInfotree provides a variety of means to generate copies of records in human readable and electronic form suitable for inspection, review and copying. Electronic records can also be copied to desktop applications for these purposes.

11.10(c)

Protection of records to enable their accurate and ready retrieval throughout the records retention period.
 

Records are protected by restricting access to authorized users.

11.10(d)

Limiting system access to authorized individuals.

The eInfotree administrator program provides an unprecedented level of control to the eInfotree system with unlimited access levels, by following these steps:

Define Users and Groups

Define Security Templates: Create security templates that control eInfotree actions and commands, including object insert, edit and delete rights. Any number of security templates can be defined.

Apply Security Templates by Group: For each group, apply any of the defined security templates to eInfotree objects. User access to the eInfotree system is controlled by their group and security template.
 

11.10(e)

Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records.

The eInfotree system includes a highly comprehensive audit trail function that captures eInfotree actions and commands, including actions that create, modify or delete data. Audit trails are secure, computer-generated and time-stamped. Recorded fields include date, time, user id, full user name, object modified, action taken, reason, old value and new value. A complete copy of the previous record is stored (refer to the next section).