TQ Software

• • • • • by TQSolutions • • • • •

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Welcome to TQSolutions

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Introduction to TQSoft and TQExpress

TQSoft is the leading thermal validation software available. It works with most leading data acquisition and calibration equipmtechnician_laptop_2ent, and can be configured for all thermal validation requirements. TQExpress report functions are integrated into TQSoft, to make validation reporting quick and efficient.

TQSoft and TQExpress have been developed by TQSolutions 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, but including measurement of pressure, humidity and other properties.

TQSoft is used for EN554, EN285, EN15883, HTM 01, HTM2010, HTM2030, ISO 17025, ISO 15883, 21CFRpart11, AMS2750D.

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 training costs, enhance productivity, improve efficiency, improve report quality.

TQSolutions has a thorough  understanding and wide experience of 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) and so thermal validation will usually be necessary to obtain FDA approval.

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•  Washer Disinfector Validation

•  Dry Heat Sterilizer Validation

•  Hot Air Tunnel Validation

•  Oven Dryer Validation

•  EtO Sterilization Validation

•  Autoclave Validation

•  Sterilizer Validation

•  Lyophilization Validation

•  Depyrogenation

•  Incubator Validation

•  Steam Sterilizer Validation

•  Freeze Drying Validation

•  Temperature Mapping Validation

•  Data Logger Calibration

 

TQSoft has drivers for ‘remote’ data loggers. This has enabled its further use in application areas…

•  Temperature Mapping Validation

•  Thermal Mapping Validation

•  Storage Area Validation

•  Stability Chamber Validation

•  Critical Thermal Validation in Transportation

For these applications in Healthcare, Pharmacy and Biotechnology TQSoft is 21CFRpart11 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 AMS2750D 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.