Activity Log

1. What is an Activity Log?
2. What is the purpose of an Activity Log?
3. What are the benefits of an Activity Log?
4. Key Features of Our Activity Log
5. CSV Download of Activity Log
6. Activity Log for Automatic System Suspension (for Tenant Administrators)
7. What is the retention policy of the Activity Log?
8. Conclusion

Maintaining a robust and transparent Activity Log is essential for maintaining a security standard and complying with regulatory expectations from the FDA's 21 CFR Part 11 and EU GMP Annex 11. It provides a structured way to track user activities, allowing administrators to monitor access and detect potential security risks.

What is an Activity Log?

An Activity Log provides the Tenant Administrators with a system-generated overview, that captures significant user actions, such as logins, password changes, and security-related events. Unlike an Audit Trail, which records modifications to electronic records, the Activity Log focuses on monitoring user behaviour (a set of actions performed by the user) and system interactions.

What is the purpose of an Activity Log?

To begin with, it helps identify suspicious behaviour and potential breaches by tracking user activity. It also enables administrators to trace potential security incidents and determine root causes, and lastly, it assists in periodic security assessments to ensure compliance and detect anomalies.

What are the benefits of an Activity Log?

• Helps investigate security breaches by providing a historical log of actions taken.
• Identifies compromised accounts by allowing organizations to review unusual user activities.
• Supports incident response teams in determining the sequence of events leading to a potential security incident.
• Provides data for periodical reviews
• Allows organizations to have an overview of authorized and unauthorized system access
• Supports compliance audits and inspections by providing an overview of user behaviours and actions

Key Features of Our Activity Log

Our Activity Log has been designed to capture detailed information about every significant action performed in the system by any user. Here’s what our Activity Log tracks:

1. Who: The system records the name, last name, and email address of the user performing the action.
2. What: The specific behaviour of the user, such as:
   • Successful log-in and successful log-out
     • Account suspension, unsuspension
3. When: The date and time of the action are logged, using the UTC time zone to maintain consistency across different regions and users.

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

• The specific action of the user
• Any other contextual information relevant to the behaviour performed.

User activity logs cover both tenant administrator and user activities. Some of the activities include:

• "User Initiated Password Reset" – Logged when a user requests a password reset.
• “User Password Reset Success” – Logged when a user successfully resets their password.
• “User Password Reset Failure” – Logged when a password reset attempt fails. The reason for failure is recorded in the Details field.
• Other logged activities: "User Suspended", "User Unsuspended", "User Creation", "Login Failure" – Logged when login attempts cannot be linked to an existing user account (e.g. due to an incorrect or non-existent email address).

CSV Download of Activity Log

Tenant Administrator can download CSV files of the Activity Log. 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.

Activity Log for Automatic System Suspension (for Tenant Administrators)

When users are automatically suspended due to inactivity, this action will now be recorded in the Activity Log. The reason will be shown as: “Suspended due to inactivity.” 

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

• Activity: The actions of the user.
• Topic (User): Select a specific user to see whom the action was performed on.
• Performed by: Select a specific user to see whom the behaviour or actions were performed by.
• Logged After/Logged before: Narrow down the Activity Log to a specific time period for more efficient searches.

What is the retention policy of the Activity Log?

The retention policy of the Activity log is 1 year.

Conclusion

The Activity Log is a vital tool for organizations operating in regulated environments. By ensuring visibility into user actions, it enhances security, supports regulatory compliance, and aids in investigations into user behaviour. Compliance with 21 CFR Part 11 and EU GMP Annex 11 further strengthens data integrity, access control, and security monitoring. Organizations should leverage the Activity Log to maintain compliance, detect risks, and safeguard electronic records effectively.