ValSuite

ValSuite is a comprehensive validation and calibration software designed to streamline thermal validation processes. It is FDA 21 CFR Part 11 compliant, ensuring full data integrity and security. The software integrates all Ellab equipment systems into a single platform, offering a unified solution for validation tasks.

ValSuite is available in multiple versions, including ValSuite Basic, Medical, Plus, and Pro, to cater to different needs. The software supports Windows 7, 8, and 10 (32/64-Bit) and is developed according to GAMP principles. It provides features such as customized reports with pass/fail criteria, test templates, data analysis, and live data monitoring.

Highlighted Features

• One platform for all Ellab equipment
• Combines TrackSense data loggers and E-Val Pro Plus systems
• Automatic PDF report generation with pass/fail indication
• Operates from a stand-alone PC or networked
• Data analysis tools reduce time to locate critical data
• Zoom and display multiple windows for data identification
• Calculates min/max, standard deviation, average, delta T, and lethality

ValSuite can handle up to 160 TrackSense channels or 120 E-Val Pro Plus channels simultaneously, allowing for detailed data grouping and analysis. It supports remote access and data monitoring via an iPhone app, enabling online data tracking from ETS, E-Val Pro Plus, and TrackSense SKY sessions.

The software offers extensive reporting options, including Pass/Fail criteria, calibration offsets, and statistical summaries. Users can create and save templates for specific tests like EN17665 and EN15883, significantly reducing the data analysis process. Reports can be reviewed and saved as PDF files.

Validation Report Types

• Lethality Report
• Limit Report
• Statistics Report
• Advanced Phase Statistics Report
• Calibration Report
• Autoclave Validation
• Washer Disinfection Validation
• MKT Report
• Combined Uncertainty Report
• Leak Test Report
• Advanced Validation Report
• Dew Point Calculation

The optional 3D Analysis tool visualizes temperature, humidity, or lethality gradients in a 3D environment, ideal for mapping. This data can be documented and presented as a video, with custom settings saved for future use.

ValSuite's Datapoint Process Report Generator (DPRG) produces fully compliant reports according to current norms and standards for validation processes and equipment qualifications. It maintains templates for specific test requirements, ensuring comprehensive and accurate reporting.