TSI, manufacturer of real-time viable particle counters and airborne particle counters for contamination control monitoring, has announced enhanced data integrity capabilities for all AeroTrak Portable Airborne Particle Counters, AeroTrak 9306 Handheld Airborne Particle Counter and BioTrak Real-Time Viable Particle Counter.
Having the capability to operate in new Data Integrity Mode, these instruments ensure complete, consistent, and accurate data according to ALCOA+ principles and enabling FDA 21 CFR Part 11 compliance.
Data Integrity Mode is enabled with the use of TSI TrakPro Lite Secure (TPLS) Software. TPLS Software comes standard on all AeroTrak Portable, 9306 Handheld and BioTrak Particle Counters. It functions as a complete data integrity solution to centralise system management, configure instruments and generate reports. At a time when data integrity remains a focus for regulatory scrutiny, these new capabilities will ensure confident compliance for all users.
“TSI’s data integrity particle counters are a game-changer for large cleanroom manufacturers looking for easy compliance according to ALCOA+ principles. We’ve taken the data integrity capabilities outside the instrument using software because it’s the only way to enable operation of an entire centralised system,” said Patrick Hutchins, TSI Global Product Manager. “This is critical to facilities to achieve easy FDA 21 CFR compliance.”
Click here to learn more about TSI Data Integrity Environmental Monitoring available for cleanroom environments within the pharmaceutical, medical device and life science industries.