Smart Audit Trail ^©

How about only having to review Audit Trail Information classified as essential?

10 to 15 x faster audit trail review
Comfortable and location independent review
Binding standards for data integrity and compliance
Fully electronic review and approval by integrated e-signature capability

Up to 10 x faster Reviews
Avoid significant licensing costs
Be compliant to GxP obligations

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Pharma
Biotech
Chemicals
Cosmetics

Time savings on review: 10 to 15 times faster

Ensuring data integrity for GxP

Intelligent filters and automated reports

Investment protection through retrofitting

Advantages of Smart Audit Trail© compared to various audit trail software solutions:

Reduction of training efforts for QC staff
Support during reviews
Intelligent reports and fully digital processing of reviews and approvals possible
Reduction of validation efforts for applications by restricting access
Monitoring of the file system for manipulation and deletion attempts of files

10 to 15 times faster Audit Trail Review

Based on a Data Integrity Assessment, all critical and audit-relevant information of a system is systematically captured.
Smart Audit Trail (SAT) is capable of specifically separating this relevant information from the rest of the data volume within the audit trail.
Thanks to a granular configuration menu, user activities, access events, and potentially manipulation-relevant actions can be individually tracked and configured - down to the level of keyboard input.
The result: Audit trail reviews per device are up to 10 - 15 x faster - while simultaneously increasing the level of data integrity and compliance.

"Thanks to Smart Audit Trail^©, we were able to continue using our existing analysis device—without costly replacements or staff retraining. The solution now fully meets all data integrity requirements and reliably protects our raw data from manipulation."

Int. US Big Pharma, Head of Production, European Site

How much effort is required for implementation and qualification?

The licensing model is tailored to your specific needs and is based on the number of control PCs to be licensed. Alternatively, a terminal server solution is also available. Before implementation, a data integrity assessment is required to guide the system configuration. The installation qualification (IQ) report is automatically generated by the system. The operational qualification (OQ) must be completed by the user for each system. We’re happy to support you with this qualification process as a service and guide you every step of the way.

By the ability to lock functionality within an application for users, the validation can be limited operationally to the functions that are actually needed for the work. Unused functionality is demonstrably not available to the user and therefore does not need to be qualified.

Smart Audit Trail^© enables the monitoring of file systems and the automated transfer of created files to network areas that can only be used by users in a read-only mode. This ensures that any manipulation is excluded.

The configuration of Smart Audit Trail^© can be exported and imported to other devices. This requires identical versions of the operating system, patch level, and version of the software application in use.

Smart Audit Trail ^©

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