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.
• 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.
• 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.
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.