Part 11 compliance software enables significant efficiency improvements in temperature measurement/validation operations.
Our dedicated software XpertLog for our system is specifically developed for the pharmaceutical and biotechnology industry, serving as validation/mapping software. Main Features: - CFR 21 Part 11 compliant: user permission settings, password management, audit trails, electronic signatures, etc. - The XpertLog software can control all systems manufactured by Lives International. - With comprehensive validation report features, including automatic pass/fail judgment functions, significant reductions in business hours are possible. - Japanese language support. *We also offer versions compatible with cloud services.
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basic information
■ Create highly reliable validation reports with one click - Setting of pass/fail criteria and automatic pass/fail judgment function - F-value calculation (customizable settings) - Trend graphs - Statistical value reports - 2D image reports and 3D video reports - Verification reports - Calibration reports ■ Compliance with 21 CFR Part 11 - User level settings (administrator, user, reporter, reviewer) - Password management and password condition settings - Audit trail - Electronic signature function ■ Control of calibration equipment - Compatible with calibration equipment from various manufacturers (Ametek, Fluke, etc.) - Automatic verification of data loggers and user calibration *For more details, please contact us.
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Applications/Examples of results
Operation of the system manufactured by Lives International, analysis of acquired data, report creation, etc.
Company information
Lives International has been providing high-performance sterilization validation and mapping temperature measurement systems to pharmaceutical manufacturers around the world for over 20 years since its establishment in France in 1998. In 2021, we opened a domestic technical base in Osaka and began regular calibration of data loggers and thermocouple systems, as well as help desk services in Japan. Moving forward, we will continue to enhance our after-sales services, including repairs, to fully support our customers' validation needs. Our research and development team is dedicated to designing products that reflect trends in the pharmaceutical industry and our customers' requests, striving daily to improve product quality. We also offer customization options. If you have any concerns regarding sterilization validation or temperature mapping, please feel free to reach out to us.
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