Audit Trail

1. What is an Audit Trail?
2. Key Features of Our Audit Trail
3. CSV Download of Audit Trail

Maintaining a robust and transparent audit trail is essential for complying with regulatory standards such as the FDA's 21 CFR Part 11. This regulation, established by the FDA, sets forth criteria for ensuring that electronic records and electronic signatures are trustworthy, reliable, and equivalent to paper records. A compliant audit trail is critical for maintaining the integrity and security of these records.

What is an Audit Trail?

An audit trail is an automatic log that tracks and records every action taken within a system, offering a clear and secure record of who performed the action, what the action was, and when it happened. This functionality is vital for accountability, data integrity, and traceability.

Key Features of Our Audit Trail

Our audit trail system has been designed to comply with 21 CFR Part 11 by capturing detailed information about every significant action performed in the system. Here’s what our audit trail tracks:

1. Who: The system records the name, last name, and email address of the user performing the action.
2. What: The specific action taken is documented, such as creating, updating, or removing a record.
3. When: The date and time of the action are logged, using the UTC time zone to maintain consistency across different regions and users.
4. The Action: Each entry specifies the type of action:
   • Create: A new record or entry is added.
   • Update: An existing record is modified.
   • Remove: A record or entry is deleted.
   • Download: A PDF or JSON file is downloaded.
   • Signature: An electronic record is signed.

To gain deeper insights into any logged action, users can click on "View Details". This feature provides more granular information, such as:

• The specific fields or data that were changed or added during an update.
• Any other contextual information relevant to the action performed.

To make it easier to find relevant data, the audit trail allows you to apply filters based on:

• User: Select a specific user to see only actions performed by them.
• Action: Filter by the type of action (Create, Update, Remove).
• Date Range: Narrow down the audit trail to a specific time period for more efficient searches.

At present, the audit trail functionality covers the following areas of your system:

• Lane Risk Assessments
• SOPs (Standard Operating Procedures)
• My Company
• My Locations
• My Suppliers

User Impersonation Visibility - Actions performed through user impersonation are now fully traceable. Hovering over the “!” icon indicates impersonation, and audit trail details show who performed the action.

 

• Remove feature for Lanes and SOPs - When a lane or an SOP is removed, multiple Remove entries are generated in the audit log, leading to an excessive number of log entries for a single action. To enhance clarity, these entries should be consolidated into a single Remove entry. This will be changed in the future.

 

 

• Changes in workflow status - An “Update” action reflects changes in signature status, for instance, when workflow changes from “In Progress” to “Approved”, the status update is recorded in the "Changes Made" section.

 

• Electronic Signatures - A new “Signature” action captures the type of signature, the User who signed, and the Role of the signer.

 

• Downloads - Two new actions have been added: “Download” and “Create.”

“Download” - Tracks when a file is downloaded and specifies the format (e.g., PDF or JSON).

“Create” - Tracks when a file is uploaded into the system.

 

• Lane & SOP Sharing/Unsharring - Sharing or unsharring lanes and SOPs are now recorded in the audit trail.

 

 

• Uploaded Files - The audit trail records actions such as uploading, modifying, downloading, and deleting files within Company, Supplier, and Supplier Locations.

 

• Workflow bulk actions for lanes and SOPs - The bulk actions, "Approve Workflow" and "Restart Workflow," allow users to select multiple lanes or SOPs and restart workflows in bulk. Note: Electronic signatures cannot be detached from electronic records.

Note: Freight Forwarders can update whether a Lane is in use at any workflow stage. Changes are recorded in both the Lane and Tenant Admin audit trails.

 

• Product Information (Manufacturer Side) - The audit trail records the creation, update, and removal of products.

 

• My Suppliers Information (excluding capability profile) - The audit trail records signatures, general information, user roles, classifications, audits, quality agreements, and downloads.

 

• My Company and Packaging Information (Packaging Providers) - The audit log records all attributes of My Company and Packaging.

 

CSV Download of Audit Trail

Tenant Administrator can now download CSV files of the Audit Trail. To ensure performance, downloads are limited to a maximum of 5,000 entries. A tooltip message appears when hovering over the download button to inform about this limitation.