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HygroLog NT FDA 21 CFR Part 11 Compliance

The HygroLog NT keeps track of the most recent 170 operations, events and configuration changes. This data is retained in the internal non volatile EEPROM memory of the HygroLog NT and is also automatically written to the flash memory card in a special logger event file. This is a protected file with includes the name of the last user and an electronic signature. When used together with the ROTRONIC HW4 software – Professional Edition; the HygroLog NT complies with the FDA / GAMP requirements regarding electronic records and electronic signatures (ERES). On models with display and keypad, the menu key should be disabled (using HW4) to prevent unauthorized or anonymous configuration changes, probe adjustments, etc. HW4 is designed to keep track of logger configuration changes, log function programming changes and of any probe adjustment. HW4 also keeps track of alarm events, user events (main operations performed by each user) and software problems. The records generated by HW4 are protected and can be signed electronically. The logger event file can be opened with HW4 and cross referenced with the other HW4 record files.
Some of the main events monitored by the HygroLog NT and example of a logger event file:
Logger configuration changed Log function programming Log function start / stop Probe adjustment Removal and installation of flash memory card Flash memory card full Instrument power up / down Alarm condition detected Probe connected or disconnected Language file change Time and date change Insertion / removal of the docking station Low battery External AC adapter connected or removed Deletion of a flash memory card file