Fluke Calibration TQSOFT-IQ/OQ
TQSoft Pharma Process Analysis and Validation Software
Fluke Calibration TQSOFT-IQ/OQ
TQSoft Pharma Process Analysis and Validation Software
- Brand Name: Fluke Calibration
- Condition: NEW
- Country of Origin: Canada
- Software from TQSolutions
- Designed to enable engineers, technicians, and lab managers to meet key guidelines for temperature data collection
- Software solutions provide complete qualification, reporting, documentation, and audit trail management system
- 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 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 quality documentation has passed FDA audits
The Fluke Calibration TQSoft TQSoft Pharma Process Analysis and Validation Software supports the Fluke 2638A and 1586A products for enhanced data collection and reporting required in regulated industries.
TQSoft provides 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.
TQSoft checks 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. TQSoft guides 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.
TQSoft allows 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 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.
TQSoft includes a large library of templates for creating reports tailored to the needs of individuals, organizations, processes, and equipment. It is 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.
Country of Origin | Canada |
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Brand | Fluke Calibration |
Condition | NEW |