COMET Cloud: Audit Trail

Key features of Audit Trail

• Automatic recording of all changes – records every action with the time and type of event.
• Login and permission changes – overview of who had access to the system and when.
• Data immutability – audit records cannot be modified or deleted, ensuring the integrity of information.
• Storage in COMET Cloud – audit reports are available in the user profile.
• Retrieval option – after the retention period has expired, the report can be regenerated by specifying a time range.
• Sending reports by email – the user receives summary records at set intervals.
• Data export – audit records can be exported to PDF or CSV format for auditing, validation, or internal control purposes.

Everything in one place – Audit Trail report content

• Each Audit Trail report provides the user with a complete overview of system activity for the selected period.
• The report is clearly structured and combines all important information into a single document – from basic data to detailed logs and statistics.

The document contains

• Basic information – device identification, report creation date, measured channels, period, and user.
• Summary for each channel – overview of measured variables, units, limits, and alarm settings.
• Statistics – minimum, maximum, and average values for the given period.
• Graphical display of data – visual overview of value development over time.
• Device records – all system events, changes to alarm profile settings, calibration, or battery replacement.
• User records – logins, changes to permissions.
• Source data – detailed tabular listing of all measured and recorded values.

Advantage

• All information is available in a single summary document – simply open the email with the report or access it directly from your user profile in COMET Cloud.
• This makes it easy to track, check, and archive all relevant data for validation or auditing purposes.

Benefits for users

• Transparent history of all activities – clear traceability of all changes in the system.
• Ensuring data integrity and security – the audit trail cannot be changed or deleted.
• Easier audits and validation – export of the audit trail for regulatory authorities or QA teams.     
• Support for compliance with 21 CFR Part 11 – meets the requirements for recording, immutability, and readability of electronic records.

For regulated environments (pharmaceutical industry, laboratories)

• Easier system validation – complete documentation of all changes simplifies the qualification and validation process according to GMP/GAMP 5 principles.
• Audit readiness – evidence of who changed what in the system and when is available at any time.
• Compliance with 21 CFR Part 11 requirements – automatic records support compliance with electronic system requirements.
• Time savings during audits – inspectors have immediate access to the necessary records without the need for manual searches.

For security and control

• Detection of unauthorized changes – immediate overview of all system manipulations.
• Protection against internal threats – clearly determines responsibility for each action performed.
• Error prevention – ability to trace when and by whom an incorrect configuration or system intervention was performed.

For system administration

• Troubleshooting – quickly identify what was changed just before the problem occurred.
• Change documentation – overview of system configuration development over time.
• User rights management – control who has access to sensitive functions and settings.

For administrative purposes

• Flexible reporting – export audit records to PDF or CSV format for internal documentation or audits.
• Automatic sending – regular overviews by email without the need to generate reports manually.
• Data retrieval – the option to regenerate records from a selected time period at any time.

Support for compliance with 21 CFR Part 11

Requirements under Section 11.10(e)
Requirement: Audit trails must contain information about data changes, time, and user.
Compliance in COMET Cloud: ✓ Each action is recorded with user identification and a timestamp.

Requirements under Article 11.10(c)
Requirement: Data must be protected against modification or deletion.
Compliance in COMET Cloud: ✓ Audit reports and records are cryptographically protected and immutable.

Requirements according to Article 11.70
Requirement: Data must be readable throughout the entire retention period.
Compliance in COMET Cloud: ✓ Reports are available online and can be regenerated for any period. 

Function availability

• The Audit Trail function is available to all COMET Cloud users.
• It can be activated in the user account administration after paying the relevant credit.
• Once activated, the feature will automatically become available in all modules of the account and will start generating audit records and reports according to the set interval.
• If you need to extend or activate the feature for multiple devices, please contact the COMET System sales department.

Summary

• The Audit Trail feature brings a higher level of security, transparency, and data credibility to the COMET Cloud system.
• Thanks to automatic tracking of all changes and regular email reports, users have a constant overview of activities in the system.
• Audit Trail ensures data integrity and traceability in accordance with the requirements of 21 CFR Part 11 and the principles of good manufacturing practice (GMP).