Ensure Compliance and Eliminate Human-error with Digital Sensor Calibration

In-line or on-line sensor calibrations, installations, and maintenance typically require logbooks and print-outs requiring extra steps for execution, review and storage, and are prone to human error. METTLER TOLEDO’s Intelligent Sensor Management (ISM) technology and iSense CFR software simplify sensor maintenance, eliminating the need for paper records and hand-written signatures to reduce mistakes. iSense CFR features ensure pharmaceutical facilities are compliant with FDA and EudraLex regulations, and significantly improve the documenting of sensor calibrations, installations and maintenance in GMP environments.

21 CFR Part 11 applies to companies selling products to the USA, whereas Annex 11 to Volume 4 of EudraLex applies to the European market. Similar to the FDA regulation, Annex 11 applies to all forms of computerized systems used where GMP regulations apply. Both regulations state electronic records and electronic signatures are equivalent to paper records and handwritten signatures, and are considered trustworthy, and reliable.

iSense™ CFR software is compliant with FDA’s 21 CFR Part 11 and EudraLex Volume 4 Annex 11 regulations, and features an electronic logbook allowing control and tracking of all probe activities. iSense is Windows-based software and features an intuitive interface and comprehensive menu to provide a fully controllable method of managing sensors, and maximising their use from first installation to disposal.

ISM is a digital technology platform that predicts sensor maintenance, increases process reliability, and simplifies traceability. Offering sensor calibration away from the process and rapid error-free measurement points at start up, ISM also features diagnostic tools that continuously monitor a sensors “health”, allowing operators to see when a sensor will need calibration, maintenance or replacement.

Download the ISM / iSense White Paper