Description

It supports all Tecnosoft BlueWave data loggers for real-time process monitoring, covering everything from thermal process validation to warehouse mapping and day-to-day quality operations.

The Basic and Pro versions meet key compliance requirements including FDA 21 CFR Part 11, GAMP5 and Annex 11, delivering powerful tools for secure data handling, analysis and professional reporting.

Why TS Manager 3

• Regulatory compliance (Basic/Pro): FDA 21 CFR Part 11, GAMP5 and Annex 11.
• Data integrity by design: non-editable device data and non-editable software data, with encryption options (Pro).
• Full traceability: tamper-proof Audit Trail of all actions performed.
• Faster workflows: modern UI and productivity features that simplify daily work.
• Scalable deployment: standalone client or Client/Server with shared database.
• Advanced analytics: graphs with zoom, multi-graph comparison, sections, and deep acquisition statistics.
• Professional outputs: customizable reports, printing, and export to HTML and XLS.

Use Cases

TS Manager 3 is ideal for pharmaceutical, healthcare, laboratory and industrial quality teams, supporting:

• Thermal process validation and sterilization monitoring.
• Warehouse mapping and temperature distribution studies.
• Equipment qualification and compliance documentation.
• Real-time monitoring with BlueWave loggers for continuous process control.
• Lethality analysis (F0, PU, A0) and Overkill validation (Basic/Pro).

Licensing & Protection Keys

Tecnosoft software licenses can be distributed either as software keys (linked to the installation PC) or as USB hardware keys (portable between PCs). With USB licensing, the license is linked to the USB key and can be moved from one computer to another. USB keys must be purchased separately from the license.

License types (differences)

• Software license: a file is provided to store on your PC. It is PC-tied and non-transferable, but does not require an external USB key.
• USB key license: transferable between PCs and required to run the software. Without the key, the software cannot start (or it will close if the key is removed during operation).

Download, Installation & Demo Mode

The software can be downloaded via TecnoUtility and works only with its dedicated hardware protection key. A Demo database with real data is available to explore the workflow and reporting capabilities. You can also download data from your loggers. The demo database resets at every restart.

Core Features

• New modern UI with an updated look & feel.
• Real-time monitoring with BlueWave loggers.
• Non-editable device data.
• Non-editable software data, with encryption options (Pro).
• User access control with login and password.
• Client/Server setup and shared database.
• Multi-user access with multiple permission levels.
• Customers and validated instruments database for validation activities.
• Audit Trail: tamper-proof recording of all operations.
• Data analysis using preset or customizable parameters.
• Pre- and post-mission comments.
• Graph and table visualization with zoom.
• Multi-graph analysis for comparisons.
• Graph divided into sections with analysis and statistics per section.
• Synchronized data table with acquisition statistics: max, min, average, max-min, max-average, average-min.
• Theoretical temperature calculation based on pressure in a saturated steam environment.
• Conversion from absolute to relative pressure.
• Lethality charts in missions and groups.
• Customizable report printing.
• Export of data and reports in HTML and XLS (MS Excel) formats.

Pro Version – Advanced Security & Real-Time Functions

The Pro version adds advanced compliance and productivity features, including:

• Set the maximum number of wrong password attempts.
• User ban time after too many wrong attempts.
• Data encryption.
• Automatic data integrity checks, even before opening a mission or group.
• Real-time lethality calculation.
• Time stamp on real-time graphs.
• And more features to streamline validation and improve audit readiness.

Technical Specifications

Full Version Comparison (Lite vs Basic vs Pro)

Standards Compatibility (Basic & Pro)

TS Manager system (Basic and Pro versions only) is compatible with the following standards: ISO 17665, ISO 15883, UNI EN 285.

Click to view the TS Manager PRO Software

TS MANAGER PRO