HORIBA has you covered — with end-to-end compliance coverage for operating A-TEEM in a GMP environment.
HORIBA provides solutions for record-keeping, method validation, and instrument verification to meet regulatory requirements around the world.
- EzPAT (OPC-UA server) provides connectivity to common PAT enterprise platforms.
- A-TEEM Direktor multivariate analysis (MVA) software is the first MVA package designed specifically for multidimensional A-TEEM data. With a complete audit trail, A-TEEM Direktor includes a seamless path from method development to model prediction, and ultimately process monitoring and control.
- IQ/OQ documentation and qualification following U.S. Pharmacopeia (USP) test methods and acceptance criteria.
