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