Access complete, human- and machine-readable logs of all activities, to maintain compliance with 21 CFR Part 11.
This 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.
As an organization admin:
Once activated, a comma-delimited text file of the audit log will be 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.
- Timestamp - Date in ISO format i.e. 2018-03-14T00:00:00Z (UTC timezone) of the action
- IP Address- IP Address of the agent i.e. user
- User Agent - HTTP User Agent string
- Acting User ID - Id of the user who made the API call
- Action - Action for the API call. i.e. project-describe, file-close, etc.
- Object ID - Id of the object i.e. project-xxxx if a project was described
- Object Name - Name of the object
- Project ID - The id of the project related to the object. Blank if an object is not related to a project i.e. globalworkflow
- Project Name - Name of the project
- Success Status - "Yes" if the API call succeeded, "No", otherwise
- Info - Input to the API call. A JSON string
- Label: The name of the user's authentication token
- Auth Token: The 4 last letters of the user's authentication token
An example of a Project with Audit Logs is shown below:
Example of a Project with Audit Logs
An example preview of a log file is given below:
If the org covers multiple regions (e.g. AWS-East and AWS-Frankfurt), the log files covering all activities in the org will be 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.