CONTROL & TRACEABILITY
Monitor System
The primary functions of the system monitor, record measurements and generate out-of-specification alarms for the temperature, humidity and gas levels within the Ethylene
Oxide Chambers. The monitoring is a live and dynamic process capable of reporting out of specification results live and at the point of report generation. Following completion of a steriliser run, the system is able outputting an electronic batch record automatically. This auto reviewed batch is available for export to the client. Hence, the batch file is protected in format that may not be manipulated during transit or review. The system is compliant with 21 CFR Part 11 (Electronic Records & Signatures). The monitoring system generates a date/time stamped audit trail for configuration changes and alarm conditions.
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