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TQTech is a data acquisition software system designed for use with MadgeTech Hi-Temp Data Loggers for the validation of steam or dry heat sterilizers, and other thermal processes. For use in Pharmaceutical and Biotech industries, by Hospitals, Healthcare and associated organizations, it is specifically designed to provide validation data for cGxP audit and process optimization. TQTech is a total qualification, reporting AND documentation system that will immediately deliver process and productivity benefits to YOUR operations. Whatever your current qualification procedures, TQTech can simplify, streamline, and reduce the cost of your validation operation. Benefits of using TQTech include: Simple Windows interface requiring minimal training No application or any other programming requirement Interfaces to multiple calibration equipment suppliers Historical trend and tabular data displays Automatic test data archiving Customized reporting (integrates existing SOP report formats!) Electronic validation report compilation and archiving Acrobat PDF le creation for Electronic distribution and storage Electronic signatures, audit trail and security, compliant with CFR21 (see p.6) Complete GAMP structured Software Validation Documentation
TQTech has all the features essential for process monitoring. User-Friendly Menu Display
Fully Configurable Chart
Selectable trace ID interval Print normal chart or zoom view Congurable limit lines All individual trace colours are selectable Digital values display at vertical time line Easily move and resize zoom box with mouse Set the number of vertical and horizontal grids Chart update in normal or zoom view Select any probe combo or display calculated variables on graph Temperature and Pressure scales on same printout, digital values display Plot Max or Min of group Option to plot uncertainty
Ultra Flexible Data List Matrix
Tabular Data Listings provide concise data summary of the measured and calculated variables of the tested cycle. Color-coded values provide easily recognized timings of limit excursions and attainment of sterilizing conditions. User selected critical cycle events and calculations are inserted for reference. Size of report is determined by user choice. Each stage duration has independent data listing frequency control to 1 second resolution. Stage event logging Congurable user colours Temperature summary Lethality management Calculated value display Logs up to 128 channels Location of max/min Include or exclude sensors
Data Management and Archiving
TQTech provides a Data Management utility to enable simple archiving and maintenance of completed test records. Test and set-up data are archived, copied or deleted without recourse to other operating systems. Users have the option of archiving at appropriate times or enabling automatic operation during testing.
21CFR Part 11 and Audit Trail Management TQTech provides a full suite of controls and features allowing encrypted security management and enabling Electronic Signature and Audit Trail logging.
The audit trail is updated automatically by TQTech. TQTech will not run if the audit trail is disabled in any way. Audit trail records and lists every relevant data modifications made by the operator and allows reason entry, and records details of changes made, and archives les for restore! TQTech even has Audit Trail maintenance, management and archive functions!
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