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
Core industries we serve
- Pharma
- Biotech
- Chemicals
- Cosmetics
Smart Audit Trail© implementation process
Smart Audit Trail© at a Glance
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.
Frequently Asked Questions
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.
How does Smart Audit Trail© reduce validation effort?
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.
How does Smart Audit Trail© prevent the manipulation of raw data?
Smart Audit Trail<sup>©</sup> 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.
Is it possible to transfer the configuration of Smart Audit Trail<sup© to other devices with the same software?
The configuration of Smart Audit Trail<sup>©</sup> 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.
Knowledge Center
The handshake Knowledge Center offers in-depth resources on Smart Audit Trail<sup>©</sup> – including whitepapers, case studies, videos, and press releases – all in one central, searchable, and accessible place.
