- The ideal solution for any thermal validation process
The FDA 21 CFR Part 11 compliant ValSuite® software is at the core of everything that Ellab offers. ValSuite will keep your process running smoothly and guard your data to secure its integrity.
The ValSuite Software
ValSuite Pro is an intuitive validation software which collects and presents validation data from all Ellab measuring devices. The software package is designed for Windows 10, 64 Bit. The software is developed according to GAMP guidelines. ValSuite is availabe in four generic versions:
- ValSuite Basic
- ValSuite Medical
- ValSuite Plus
- ValSuite Pro
The ValSuite Pro version has all features and all reports and is fully validated and compliant with 21 CFR, Part 11. Full IQ/OQ documentation and validation services are available from Ellab.
The software is currently available in Chinese, Dutch, English, French, German, Italian, Japanese, Polish, Portuguese, Russian, Spanish, Swedish and Turkish.
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A complete set of reports can be produces containing Pass/Fail criteria, map over measuring positions, current operator and vessel ID, calibration offsets for the probes, data lists and statistical summaries of the data.
ValSuite Pro also allows users to create and save templates for reports in order to meet the specific requirements of tests like EN17665 for moist heat autoclaves, EN15883 for washer disinfectors or NFC 15-140 for stability chambers. These templates can be customized to organize the data and perform calculations to match various criteria. These features greatly reduce the data analysis process.
Once ready, reports can be reviewed using the print preview feature and then be saved as a PDF file.
Validation Report Types
The different reports include, but are not limited to:
- 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
- And more...
Windows Security Option
ValSuite Pro has the unique feature of being Windows Security compatible. Through this feature, administrators can setup the ValSuite login/access levels for their users via AD groups. These groups can be provided with different rights depending on the tasks that they perform or the information that they may require. By implementing this, data and various content remains secure as only authorised personnel may access it at any given time. This is a highly time saving feature, as each specific user no longer needs to be manually created or maintained within the software. It is easy to set up and is completely Windows Authenticated.
Ellab’s wired thermocouple system, E-Val™ Pro, can also be managed via the Windows Security feature. Ensuring that all users are only able to access options and features permitted for their specific group or role.
Features and Benefits
- Safe & reliable
- Windows authenticated & compatible
- Time saving use of AD’s and groups
- Easily manageable
- Additional Windows Security for wired thermocouple module
FDA 21 CFR, Part 11
The ValSuite Pro version of the software is fully validated and FDA 21 CFR, Part 11 compliant. Electronic signature and audit trail features are included in addition to the wide range of validation, calibration and monitoring features within the software. As ValSuite Pro is fully compliant, all data and documentation received from studies or tests are considered reliable and trustworthy by regulatory bodies.
Main Validation Features
- One software for both TrackSense® Pro loggers and E-Val™ Pro wired systems.
- Can run as a stand alone PC or a server/Citrix solution. Network security can be applied.
- Full synchronization of all data removing all possible “phantom” values from reports.
- Up to 160 measuring points in a singe session.
- Easily switch between multiple languages.
- Drivers for calibration equipment.
Detailed Test Setup
ValSuite Pro software also offers several monitoring type features such as on screen statistical calculations, limit alarms, alarms over internet and notification via e-mail services. Further to this, a “transport logger” function makes it possible to start and read the logger from two different databases / PC’s thus allowing the logger to be used to monitor parameters during transportation over long distances.
Software Data Analysis Features
Data analysis tools greatly reduce the time needed to find critical data. The ability to zoom graphically and display multiple windows at once simplifies identifying important data. Multiple calculations such as min/max, standard deviation, average, deltaT and lethality can be calculated on any block of data displayed eliminating the need to export data thus improving data security. ValSuite Pro collects and presents validation data from both E-Val™ Pro and TrackSense® Pro data logging systems. The data from both systems can be presented and analyzed in the same session. The system can run up to 128 channels which can be identified and displayed in different groups such as penetration and distribution. Any grouping or specific channels can be displayed in a separate data block and analyzed. It is also possible to merge individual sessions and run analysis for comparison purposes.
Detailed Control of Validation Studies
The ValSuite Pro software documents and guides you through the complete thermal validation process. The database structure in the software enables complete documentation and procedural control for the operators.
And much, much more...
ValSuite™ Calibration Features
ValSuite can also be used as a calibration software, which means that all probes can be user calibrated or verified at defined intervals, while all offset values are stored in the same database with full access. Upon completion, a report is automatically generated, showing the overall calibration results.
Features & Benefits
- Easy step-by-step setup
- Up to 6 calibration points at a time
- Completely compatible with Ellab’s calibration equipment
- Special software versions for other manufacture equipment (OEM)
- Direct downloads of calibration certificates via the Ellab Cloud
The ValSuite software includes setups for executing three different calibration methods for temperature sensors. The calibrations are controlled within the software, while the offset points are stored in the thermocouple plug (for wired thermocouple systems) or within the software database (for wireless data loggers).
- Full-Automatic calibrations
Easy and time saving setup by uploading a predefined template. The software will then execute the entire calibration process without requiring an operator. A LiquidCal bath or dry block is required in combination with our Ellab Temperature Standard (ETS) sensor and the ValSuite Software.
- Semi-Automatic calibrations
Connect the Temperature standard (ETS) to a PC running ValSuite. The operator is only required to change the setpoints.
- Manual calibrations
Require a fully present operator and is performed without the bath/dry block and ETS being connected to a PC. This procedure can be used for all parameters, while still taking advantage of the templates with predefined criteria.
Calibrating Other Measuring Paramaters
When using a manual calibration setup within the ValSuite software, it is possible to calibrate, and even adjust, sensors with measuring parameters like pressure, relative humidity, CO2, conductivity and vacuum. The data obtained from the sensors being tested, is then manually compared/synchronized to a reference value before issuing a report.
ETS Suite - Calibration Software
The stand-alone ETS Suite software, offers an easy configuration for one or multiple ETS units, with regard to data collection and analysis. The software provides a statistical and limit report output, as well as traceability and/or notifications for the due factory calibrations.
The ETS Suite software is typically used when the ETS is required for other purposes than being a part of an Ellab validation system. As the ETS is a versatile reference instrument, it can even be used in calibration processes where sensors remain mounted within an autoclave. If the ValSuite software is already at hand, a special menu for the ETS is added, offering the exact same features and functionality.