21 CFR PART 11 COMPLIANCE


TRINITY V3 strictly complies with 21 CFR Part 11 electronic signature requirements from reading test plates to reporting test results including:
  • Three level access control with user ID and password (Read Only, Standard User, Administrator)
  • Password expiration settings
  • Minimum password and user ID length settings
  • Secure, encrypted database
  • User access log and data audit trails
  • All changes to users, configuration, and system settings are logged
  • All test results are marked with user ID, date and time

TRINITY V3 settings can be customized to meet your laboratory compliance requirements.
Customer Testimonial - 21 CFR Part 11 Compliance

"TRINITY V3: A reliable instrument for our USP antibiotic potency assays"

"The TRINITY V3 is flexible and very reliable for our USP antibiotic potency assays. The optics  produce high quality images and the software interface is easy to use and navigate. It allows for visual verification of the inhibition zones on screen. TRINITY V3 is also fully compliant with 21 CFR Part 11 requirements."

Tom Dougherty
Fresenius Kabi
Grand Island, NY, USA
TRINITY V3 customer since 2007

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