Audit trails are key to the security of a system since they record every change performed within the application. Their presence in the system brings integrity and accountability to your organization. OneLab audit trails comply with Part 11 §11.10 (e) requirements.
Each audit trail contains:
The full name of the user who performed the action
The timestamp of the action
The type of the action (e.g. "Full name locked and signed protocol")
The content item to which the action was applied
The previous and the new value of the content item
When applicable, the reason for the change provided by the user when the action was applied
Being keen to maintain the software as easy to use as possible, reasons for the change are only required for critical actions (see the annex at the end of this article). In any case, the system will record reasons entered by users when requested.
Note: Audit trails are always recorded and cannot be turned off.
There are TWO different user-restricted audit trails in OneLab:
1 - Lab audit trails
Only accessible for users with the "Lab Admin" role.
This audit trail contains changes performed on: users (lab members), devices, tools, projects, protocol, reagents, samples, and experiments.
This interface is accessible from the lab menu (top left of the screen):
All audit trails are listed in reverse chronological order:
You can filter audit trails by selecting a date range and by choosing all or a certain item type.
By clicking on the "Export filtered audit trails (.csv)" button (on the top right of the screen), you will obtain a tabular data file (.CSV) that contains all the info of current audit trails filtered in the table.
To view the exhaustive information of a particular audit trail, click on the corresponding row, you will obtain a screen that displays the detailed information:
2 - Platform audit trails
This interface is only accessible for users with the "Platform Admin" role and contains an audit trail of system-wide changes including administrative actions.
The audit trail table is accessible by clicking on the corresponding menu item in the "Platform admin" interface (only available for Enterprise deployment)
The user interface for viewing platform audit trails shares the same functionalities as that of the lab audit trails" (list, detailed view, pagination, filters, and export feature).
ANNEX | List of critical actions where OneLab requests a reason for the change
When the Platform Admin...
When the Lab Admin...
When the Lab Admin or the Expert User...
When the Lab Admin, the Expert User, or the Operator...