VALSUITE™

 
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A totally new platform has been created for the ValSuiteTM Pro 4.0:

  • New Metro style Desktop with pdf reports
  • SQL Server Express 2012, Database
  • New Report layout
  • Easy operation – Repeat function
 
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Detailed Control of Validation Studies
The ValSuite™ 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. 

Test Setup
Templates allow detailed test criteria to be pre-set in the software by the assigned administrator. Information on sensor placement, operator, test, vessel, required temperature limits, start and stop time, monitoring interval and specific calculations can all be pre-set and saved. This ensures accurate documentation and correct implementation of required procedures for consistently repeated tests.

 
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Pre-identifying sensor positions greatly reduces setup time and errors. A test setup sheet is an indication where each sensor should be placed. Later during analysis this information is easily displayed and tracked. 

Software Data Analysis Features
Data analysis tools greatly reduce the time needed to find critical data. The ability to zoom graphically and display up to 8 tiled windows at once simplifies identifying important data. Multiple calculations such as min/max values, standard deviation, average, deltaT and lethality can be calculated on any block of data displayed.  This eliminates the need to export data which improves data security.

ValSuite™ collects and presents validation data from both real-time E-Val Flex and TrackSense® Pro wireless 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.

 

Outputting Reports
A complete thermal validation report can be produced with pass/fail criteria, detail on mapping positions, operator and vessel ID, calibration offsets for sensors, full data lists and statistical summaries on the data. ValSuite™ also maintains templates for reports designed to meet specific requirements of tests such as EN17665 (EN554). The templates can be customized to organize the data and perform calculations to your exact criteria. Offering this greatly reduces the time needed for the data analysis process. Reports can be reviewed with the print preview feature and a pdf file document is generated.

 
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Maintain Security
ValSuite™ Pro operating software is designed to maintain the highest level of security for compliance with 21 CFR Part 11. The software administrator controls and assigns user ID and access privileges. Any user function can be deactivated which will deny access for specified users. This significantly reduces the risk of mistakes applies tight control of usage by the administrator. 

Raw data cannot be changed and user actions are recorded in the audit trail. Any analysis of data such as time markers, limits or comments will be recorded in the audit trail. Analysis reports can be produced with an electronic signature with the ID of the user generating the report. Accessing information from the audit trail is simplified with the ability to search by date, study ID, user ID and vessel ID.

 
Compliant to FDA Guidelines
  • Raw data is built into a database structure and cannot be modified or erased
  • Complete audit trail with easy search engine to find data by date, session, user and module
  • User ID and passwords with detailed user access control
  • Sensor ID provides complete NIST traceability
  • Customized report generator eliminating need to export data
  • Specific compliance reports (e.g. EN17665)
  • Automated pre and post calibration reports
  • Print preview feature with report output in pdf file format


    GAMP Guidelines and DS/EN ISO 9001
    All documentation for the development of ValSuite™ Pro software is in accordance with the guidelines set out in GAMP. Software package includes appropriate documentation. Ellab's quality system is compliant with DS/EN ISO 9001.