Processes of temperature monitoring in the healthcare field require constant validation and must follow strict regulations, particularly the Federal Drug Administration (FDA)'s 21 CFR Part 11.
Tecnosoft, with its wide experience of temperature data loggers development, provides a full range of solutions for sterilisation monitoring and many other applications in the pharmaceutical and medical markets.
Tecnosoft's new software, TS Manager, is compatible with SterilDisks, which are widely used in the food and pharmaceutical industries to control high-temperature processes of up to 140°C. The software has been designed according to FDA regulations and has been approved as 21 CFR Part 11 compatible.
TS Manager also works with other loggers, including SterilCyl, for bottles monitoring and narrow places, and TempStick, suitable for environment, fridges, fridge cells and transport monitoring, as well as many others.
The TS Manager enables users to start and download several loggers at once and analyse acquired data through different profiles using formulas and parameters such as F0 and mean kinetic temperature, to immediately check the monitored process.
TS Manager is a multi-user software with login, password and permissions. All operations are logged and data cannot be modified, as requested by the regulations.
The software is also designed for validators requiring a quick and powerful solution to validate customers' processes and equipment. Tecnosoft offers a validation kit, which includes three temperature loggers and a temperature and pressure logger, at a highly competitive price.
The company can save a customer database, and for each customer its equipment, and have the history of all validation. Tecnosoft can then print detailed reports and export data in XML and PDF, with digital signature implementation.