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Secure, configurable FDA 21 CFR Part 11 capable software for use with TSI AeroTrak and BioTrak Particle Counters to facilitate cleanroom classification reporting and enhanced data integrity.
TSI TrakPro™ Lite Secure (TPLS) Software works with select AeroTrak® Handheld and Portable Airborne Particle Counters as well as BioTrak® Real-Time Viable Particle Counters to produce professional classification reports. TPLS Software reviews the data collected against common standards and assures all test requirements (such as minimum number of test locations, minimum sample volume, and more) have been met to determine if the testing is valid and assesses results against classification limits to assign a pass/fail result.
TPLS Software can also be used to enhance data integrity, assuring that data is complete, consistent, and accurate per ALCOA+ principles, when used with the following instruments that are capable of operating in Data Integrity (DI) Mode:
When operating these instruments in DI Mode, TPLS Software takes over as a centralized location for user management, instrument configuration and report generation. DI Mode ensures these activities are performed in an FDA 21 CFR Part 11 capable environment.
To learn more about TSI data integrity particle counters, click HERE.