ICP-MS Intergrated with Enterprise Content Management System For Regulated Pharma Applications

Agilent Technologies, Inc has announced that its 7500 Series inductively coupled plasma mass spectrometer (ICP-MS) is now fully integrated with the company’s OpenLAB enterprise content management (ECM) system. The integration makes the power of ICP-MS more accessible to a wide range of regulated pharmaceutical QA/QC labs, which have been adopting the technique in growing numbers. “The Agilent ICP-MS system is
very good at quickly detecting trace levels of inorganic impurities in drugs and can measure a full suite of elements in a single run,” said Katja Kornetzky, Agilent Solution Manager, Pharma QA/QC. “Now, it easily can meet 21 CFR Part 11 compliance requirements.”
The 7500 Series enables interference-free analysis of all elements in any matrix under a single set of operating conditions. Its Octopole Reaction System (ORS) removes interfering species using only inert helium gas (He mode), which vastly improves speed and accuracy.
Agilent’s OpenLAB ECM is a scalable operating system for instruments and all formats of laboratory information.
The Web-based system lets users capture, manage, share, archive and retrieve all types of electronic files, from instrument data through Microsoftâ„¢ Office documents. The system enables complete management of laboratory information. All files in OpenLAB are under audit trail and revision control. These files now include data from Agilent ChemStation data software for ICP-MS, which can be automatically uploaded into the ECM system.
To ensure data security, access to ICP-MS ChemStation/ OpenLAB is protected by a unique username and password.
All raw data and reports belonging to a particular run are transferred from the ICP-MS ChemStation to OpenLAB in a “container” file. All capture and changes to data are recorded in a time-stamped, automatically generated audit trail. Users can sign off on the data using the OpenLAB electronic signature. The Agilent 7500 Series delivers
category-leading levels of performance for analysing trace levels of metals. The platform is also known for ease of use, flexibility and traditional Agilent reliability. Agilent is also an industry leader in compliance services, including the new Installation Qualification and Operational Qualification/ Performance Verification, and this support can now be extended to the ICP-MS platform.