Audit trails are key to the security of a system since they track every changes performed within the application.

Their presence in the system bring integrity and accountability to your organization.

OneLab audit trails comply with Part 11 ยง11.10 (e) requirements.

Each audit trail contains:

  • The author's full name (and internal user ID) of the action

  • Date and time stamp of the moment when the action occurred

  • A change summary that helps you understand what type of change has been done (i.e.: "Full name locked and signed protocol")

  • The identification of the content item to which the change was applied

  • Both entire previous and new value of the content item

  • When applicable, a reason for change provided by the author at the time of the action

In order to keep the software as easy of use as possible, reasons for change are only required for critical actions (see list at the end of this article). In any case, the system will record reasons entered by users modifying the records.

Note: Audit trails are always recorded and cannot be turned off.

There are 2 different user restricted access for audit trails in OneLab

1 - Lab audit trails

Only accessible for user with "Lab admin" role.

This audit trails contains changed performed on: users (lab members), devices, tools, projects, protocol, reagents, samples and experiments.

This interface is accessible from lab menu (top left of the screen):

All the audit trails are listed in a 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 "Export filtered audit trails (.csv)" button (on 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:

Note: Users with "Expert user" role can access an high-level view of protocol changes (via the protocol history panel or OneLab dashboard)

2 - Platform audit trails

This interface is only accessible for user with "Platform admin" role and contains audit trail of system-wide changes including administration actions.

Audit trails table is accessible by clicking on the corresponding menu item in the "Platform admin" interface (only available for Enterprise deployment)

The user interface to allows to view platform audit trails share the same functionalities of the lab audit trail" (list, detailed view, pagination, filters and export feature).


Annex: List of critical actions where OneLab request a reason for change

When Platform admin...

  • updated someone password

  • unassigned user from lab

  • disabled user account

  • forced user to logout

  • reset user password

  • unassigned user from lab

  • archived lab

  • unarchived lab

When Lab admin...

  • unassigned user from lab

  • left lab

  • archived project

  • unarchived project

  • archived protocol

  • unarchived protocol

  • archived experiment

  • unarchived experiment

When Lab admin or Expert user...

  • locked protocol (and eventually signed)

  • unlocked protocol

  • restored previous version of protocol

  • removed device from lab

When Lab admin, Expert user or Operator...

  • updated device license

  • aborted experiment

  • released experiment report (and eventually signed)

  • reviewed experiment report

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