For FDA 21 CFR Part 11 and AMS 2750 Compliant Data Collection
The Fluke 2638A Hydra Series III ? and Fluke Calibration 1586A Super-DAQ ? are ideal for general purpose and precision temperature data acquisition applications. Thermal validation software from TQSolutions has long supported the Fluke Hydra Series data loggers. TQSoft and TQAero now support the Fluke 2638A and 1586A products for enhanced data collection and reporting required in regulated industries.
Many data acquisition applications require compliance to government and standards agency requirements (for example, 21 CFR Part 11 and AMS 2750). Software from TQSolutions has been designed to enable engineers, technicians, and lab managers to meet the key guidelines for temperature data collection. These software solutions provide a complete qualification, reporting, documentation, and audit trail management system.
TQSoft
? Compliance with United States Food and Drug Administration (FDA) Title 21 CFR Part 11 regulations on electronic records and signatures for incubation, sterilization, freezing, drying and temperature mapping validation applications in pharmaceutical and biomedical industries.
? Developed in accordance with Good Automated Manufacturing Practice (GAMP) from the International Society for Pharmaceutical Engineering (ISPE).
? Compliance with European standards for sterilization, decontamination, and disinfecting (EN554, EN285, EN15883, HTM2010, HTM2030), ISO 15833 requirements for washer-disinfectors, and ISO 17025 competence requirements for testing and calibration laboratories.
? Has been audited by major pharmaceutical companies and its quality documentation has passed FDA audits.
TQAero
? Compliance with National Aerospace and Defense Contractors Accreditation Program (NADCAP) and SAE International AMS 2750 guidelines covering industrial heat treating applications in aerospace and transportation industries.
? Supports heat treatment processes validation by Temperature Uniformity Survey (TUS) and System Accuracy Test (SAT) procedures required by AMS 2750.
Key features
Easy menu system and toolbar
TQSoft and TQAero provide a menu system designed to simplify thermal validation test setup. The left panel guides you step by step. Dropdown arrows on the right list the full range of options. If desired, easily switch to the toolbar for access to all software features.
Data security and audit trail
TQSoft and TQAero check data files used to produce reports. Any changes made by an unauthorized person will render records unusable. All changes made by an authorized user are audited with full details of the changes made and actions performed.
Test equipment preparation and sensor calibration
Both TQSoft and TQAero guide you through data logger channel configuration and communications setup with a temperature source, thermometer readout, and reference probe. Fluke 2638A and 1586A models are automatically detected as data loggers for easy setup. Prior to a thermal validation test, an automatic or manual sensor calibration can be performed to determine multiple point offsets for each channel to correct for sensor measurement inaccuracy. When the sensors and reference probe are detected to be stable as defined, the software automatically applies all correction offsets, generates, and saves a full and traceable calibration report.
Thermal validation test setup
TQSoft and TQAero allow you to set up and manage a three-dimensional (3D) wire diagram of the chamber space. Drag and drop sensors to their correct position in the 3D space. The completed diagram can be rotated and magnified. There are options for real time display of measurement values and to represent temperature gradients with color shading at each sensor position. After the test is complete, a real time display can be replayed with a time slider showing temperature behavior in the chamber. Completed diagrams can be easily added to reports.
Sample test specifications
Sample test specifications are included to help you quickly become familiar with the software. The test specification contains selection settings for target temperature, channel configuration, all calibration information, and all temperature parameters. When you select a test specification and start a test, all settings are automatically applied by the software, and a report can be automatically generated at the end of the test. Once you are familiar with the software, you can make modifications and create new test specifications to meet your specific needs
Reports
TQSoft and TQAero include a large library of templates for creating reports tailored to the needs of individuals, organizations, processes, and equipment. It’s easy to assemble a full report from the report sections. Cover pages, charts, data lists, calibration reports, calibration certificates, etc. can be included. The Report Manager window has been designed to manage and print complete reports.
Fluke Calibration instruments supported
Data acquisition systems
1586A Super-DAQ Precision Temperature Scanner
2638A Hydra Series III Data Acquisition System / Digital Multimeter
2620A/2625A Hydra Series Data Acquisition Unit / Data Logger
2635A/C Portable Data Acquisition
2680 Series Data Acquisition Systems
2640A/2645A NetDAQ Data Acquisition Unit
Thermometer readouts
1502A and1504 Tweeners
1523 and 1524 Reference Thermometers
Temperature sources
9142, 9143, and 9144 Field Metrology Wells
9190A Ultra-Cool Field Metrology Well
9170, 9171, 9172, and 9173 Metrology Wells
9103, 9140, and 9141 Dry-Well Calibrators
9009 Dual-Block Calibrator
9011 Dual-Well Calibrator
9101 Zero-Point Dry-Well
9007 Portable Lab Dry-Well
6102, 7102, and 7103 Micro-Baths
6330, 7320, 7340, and 7380 Compact Baths
6331, 7321, 7341, and 7381 Deep-Well Compact Baths
9150 Thermocouple Calibration Furnace
System requirements
One of the following Microsoft operating systems:
Windows XP
Windows 7
Windows 8
Disk space: 250 MB
Languages
English
Demonstration
Contact your Fluke representative to arrange a demonstration of the software.
Pricing
Contact your Fluke representative to request a quote.
Support and training
For customers setting up complete validation systems, more extensive support and training is recommended and usually required. A range of customization and training options is available for TQSoft and TQAero. Contact TQSolutions at [ protected] to discuss your training requirements.
