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Thermal Process Validation System XpertLog |
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Secure Access, Instrument Identification and Data Traceability – complete cross-reference of the instruments, users, and time of events for the calibrationand test files. User identification (ID and password) required for system access and use. Audit trails generated automatically on event. Automatic Calibration and Test Control – - off-line and in-line calibration / verification - user-selected temperature block (e.g. Lives) and Temperature Reference Standard fully controlled by the software. Data Protection – raw data stored in the data logger memory and in a protected database on the PC hard drive; electronic signature compliant; fully FDA 21 CFR Part 11 compliant Reports: - user customizable - define loggers & intervals to appear - user configurable - generated automatically - different time intervals during same cycle - unlimited number of loggers in the report - multiple points for calibration / verifications Export & Import – administrator-configurable for calibration and test files. Data availability for custom reports and “off-line” data analyses. GENERAL FEATURES : Comply with EC & USA thermal validation regulations cGMP, EN554, EN285, HTM 2010 compliant |
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