TQSoft™ and TQAero for Thermal Validation Systems
TQSoft™ is the leading thermal validation system software available. It works with most leading data acquisition and calibration equipment, and can be configured for all thermal validation system requirements. TQExpress report functions are integrated into TQSoft™, making validation reporting quick and efficient.
TQSoft™ and TQExpress have been developed by TQSolutions Ltd. since 1994 with GAMP procedures to provide thermal validation engineers with project specification, calibration management, data collection, data analysis, and reporting tools targeted to thermal validation requirements, including measurement of pressure, humidity and other properties.
TQSoft™ is used for EN554, EN285, EN15883, HTM 01, HTM2010, HTM2030, ISO 17025, ISO 15883, 21CFR Part 11, AMS2750, CQI-9.
Validation engineers and contract validation companies will find that the functions available in TQSoft™ will match their expectations in quality and functionality. TQSoft™ will reduce thermal validation system training costs, enhance productivity, improve efficiency, improve report quality.
TQSolutions Ltd. has a thorough understanding of, and wide experience with, thermal validation requirements and can provide validated data acquisition and calibration systems configured to your applications. We can also provide thermal validation services that will help you achieve FDA approval.
The FDA Code of Federal Regulations requires that companies involved in pharmaceutical, biotech, medical devices, Nutraceutical, and Cosmeceutical industries employ validation practices as an essential part of their compliance strategies. Temperature is an important factor in many process operations (incubation, manufacturing, storage, stability, sterilization, freezing etc), so thermal validation will usually be necessary to obtain FDA approval.
TQSoft™ has drivers for remote data loggers. This has enabled its further use in application areas:
For these applications in Healthcare, Pharmacy and Biotechnology TQSoft™ is 21CFR Part 11 compliant and has been developed in accordance with GAMP. It is used to help our customers to comply with HTM2010, HTM2030, HTM01, EN 554, ISO 15883, ISO 17025.
For applications in heat treatment TQSoft™ complies with NADCAP and is used to help our customers comply with AMS2750 guidelines for Temperature Uniformity Surveys (TUS) and System Accuracy Tests (SAT) and thermocouples usage monitoring.
TQSoft™ has been audited by major pharmaceutical companies and its quality documentation has passed FDA audits.
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