Digital Compliance for pharma. Search, monitor and compare GxP data without endless PDFs.

TRACKS integrates with your Active Directory to handle all users and access rights.

Access rights are role-based and support users having different roles on different machine groups.

Authentication and authorization is centralized in TRACKS.

Audit trails are generated immediately in TRACKS whenever any electronic records, such as parameters, are changed.

TRACKS also supports the storage of audits from other systems and offers custom importers and exporters, for seamless integration with external systems. Standard importers and exporters exist for XML, JSON, SQL servers, OPC UA, and CSV files.

Audits adhere to regulations and include at least the following:

• Timestamps with date, time, and time zone.
• Clear, legible, and indelible records.
• Information about who made the changes.

Events such as authentication and alarms are automatically saved in the audit trail.

All audit table columns can be easily sorted, filtered, grouped, and saved in physical formats such as PDF or CSV.

Parameters in TRACKS are data obtained from other systems.

TRACKS retains a full history of all parameters, ensuring a detailed record of changes over time.

Parameters offers the following features:

• Monitoring: Parameters can be marked as critical for easy monitoring.
• Automatic Audit Trails: All changes to parameters are automatically logged into the audit trail.
• Custom importers and exports: The system provides a standard interface for third-party systems to enable custom import and export of data.

TRACKS allows users to create baselines, which are snapshots capturing the state of all parameters at a specific moment. Users can easily view or compare these baselines within the application.

Parameters across the system can be compared at any two given points in time, facilitating easy comparison during Factory Acceptance Tests (FAT) or Site Acceptance Tests (SAT).

When comparing baselines, new parameters, changes, and deleted parameters are color-coded. Baselines can also be exported to physical formats such as PDF or CSV.

Audit data and parameters can be easily sorted, filtered, grouped, and saved in physical formats such as PDF or CSV.

The Equipment module in TRACKS serves as a platform for overview and maintenance of testing equipment, which includes devices monitored for service and calibration.

Additionally, the system provides functionality for creating equipment lists for tests and other related activities.