A-TEEM Compliance Package

Solutions for Operating an A-TEEM Spectrometer in a GMP Environment

HORIBA’s new A-TEEM Compliance Package provides solutions for record-keeping, method validation, and instrument verification to meet regulatory requirements.

A-TEEM Compliance Package

A-TEEM Direktor Software

How can the Compliance Package help use A-TEEM in a GMP Lab?

IQ/OQ Validation

IQ/OQ Validation documentation and qualification following US Pharmacopeia test methods and acceptance criterial ensuring your data is reliable, reproducible, and meets expected performance requirements.

EzPAT OPC UA Server

EzPAT OPC UA Server is available to make Aqualog connectivity and control available from PAT Enterprise Software packages. OPC UA protocols and PAT Enterprise software packages handle user login authentication, data integrity, and electronic records keeping as required by US FDA 21 CFR Part 11 and similar regulatory requirements globally.

A-TEEM Direktor

A-TEEM Direktor Multivariate Analysis Software is a new MVA software designed specifically for A-TEEM multidimensional spectral data and includes user login authentication functionality and complete audit trail capability for GMP compliance needs. And it is easy to understand too.

EzSpec‑P11

EzSpec-P11 enhances HORIBA Veloci and Aqualog UV-800 systems with advanced data integrity, audit trail, electronic records, and electronic signature capabilities, helping regulated laboratories support GMP workflows and compliance with FDA 21 CFR Part 11 requirements.

A-TEEM is faster, more sensitive, and has lower detection limits than current PAT spectroscopic solutions

Get precise analysis of complex mixtures with A-TEEM: The spectroscopic tool for speed, sensitivity, and low detection limits. And now with this new compliance package, A-TEEM is a spectroscopic solution that can be used to identify low level components in complex mixtures or identify contaminants and out of spec product and offers end-to-end coverage for a GMP environment.

A-TEEM™ Molecular Fingerprinting is a new optical technique that is ideal for comprehensive component analysis in a variety of QC/QA applications, particularly, pharmaceuticals. It is a simple, fast, “column free” spectroscopic technique that simultaneously measures the absorbance, transmission and fluorescence of samples in solution, and is faster and easier to operate than traditional analytical techniques, such as chromatography, mass spec, IR, etc.

An A-TEEM spectrometer:

Compact optical spectrometer based on simultaneous Absorbance-Transmission fluorescence Excitation Emission Matrix (A-TEEM) spectroscopy.
Captures a full emission spectrum at every excitation wavelength while simultaneously collecting the absorbance spectrum.
Automatically corrects for Inner Filter Effects to ensure that your data has truly accurate fluorescence fingerprints.
Provides inter and intra-lab comparability with NIST-traceable corrected spectra.