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Audit Trail

Access complete, human- and machine-readable logs of all activities, to maintain compliance with 21 CFR Part 11 (Annex 11).

A license is required to use the DNAnexus Audit Trail feature. Contact DNAnexus Sales for more information.

The DNAnexus Audit Trail feature fulfills the 21 CFR Part 11 requirement for human-readable audit trails for electronic records. The Audit Trail feature provides human and machine-readable daily log of all activities (login, upload/download, run analysis, sharing etc) related to all the users and all the projects of the organization.

Enable Audit Trail

As an organization admin:

Create a new project for storing audit log files
or a point of contact at DNAnexus and with the organization name and project ID to enable the feature

Once activated, a comma-delimited text file of the audit log is deposited daily in designated project. Until the feature is activated, no data is being tracked. The organization administrator can subsequently provide other members of their organization with access to this project.

These audit log files can be downloaded for further analysis.

DNAnexus is not able to access these files or restore them if deleted. It is therefore recommended to from this project to prevent this.

Audit trails cannot be turned off except by . Only administrators can send requests.

Audit Trail File Format

Timestamp - Date in ISO format, such as 2018-03-14T00:00:00Z (UTC timezone), of the action
IP Address- IP Address of the user
User Agent - The string

An example of a Project with Audit Logs is shown below:

If the org covers multiple regions, such as AWS-East and AWS-Frankfurt, the log files covering all activities in the org are placed in a project which is the default region of the org. To determine the specific region where the audit activity occurred, map the IP address to a geographic address.