Product/Service

Continuous Monitoring Systems: Pharmaceutical , Biopharma

Source: Vaisala, Inc.

Compliant w​ith major regulatory regimes.

The system ensures data integrity with an audit trail, access controls, encryption, and authority levels that fulfill regulatory requirements. Compliance is simplified with validatable software, mapping/qualification capabilities, encrypted data and audit trail, optional, protocols and GxP documentation, ICH-compliant calibration options. Reports comply with GxP guidelines and standards, as well as FDA 21 CFR Part 11, EU Annex 11, ICH​​, etc.

Industry-best sensors, proven performance

Choose from a wide selection of transmitters, data loggers and probes. Options include wall, duct, and remote probe mounting capabilities. Temperature measurements range from -196 °C … + 1000 °C and humidity measurements to 100%RH. Measurements are traceable to SI units through national metrology institutes.

Fully configurable

With a variety of alarm notifica​tion options and reports, the system is fully configurable to meet your needs. Data is logged continuously and autonomously at the point of measurement ensuring it is never lost to power or network downtime. Devices are easy to network through any combination of connectivity options, including Ethernet, PoE, or Wi-Fi.