23 May 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Agilent Technologies launched ‘OpenLAB Data Store for MS', a simple and affordable networked solution for compliant storage of mass spectral data acquired with Agilent's ICP-MS MassHunter system. The software is designed for medium to small laboratories measuring inorganic impurities in pharmaceutical products and ingredients in accordance with upcoming specifications from the US Pharmacopoeia.
The OpenLAB Data Store for MS bundle allows customers to grow their compliant data storage to a second ICP-MS system at a lower price than standalone workstation solutions. The US Pharmacopoeia has proposed two new general chapters to test for inorganic impurities in pharmaceutical products and ingredients, including Elemental Impurities-Limits and Elemental Impurities-Procedures.
These elemental impurities are most efficiently measured using ICP-MS because of its low detection limits, dynamic range and throughput. Electronic management of the ICP-MS data is required as defined in Part 11 of the U.S. Food and Drug Administration's Code of Federal Regulations (21 CFR Part 11) and the European equivalent (EU Annex 11).
For lab managers who oversee one to 15 ICP-MS MassHunter systems, OpenLAB Data Store for MS offers benefits such as affordable with cost-effective deployment and administration for a lower total cost of ownership; efficient central storage and retrieval of ICP-MS MassHunter data; and networked solution with centralized system management boosts productivity. It also supports US FDA 21 CFR Part 11 and EU Annex 11 compliance for USP <232>/<233> with comprehensive data security, audit trails and e-signature authorization and is based on industry-standard technology.
Dr Bruce von Herrmann, vice president and general manager, software and informatics business, Agilent, said that, "Target ICP-MS labs need a networked solution for US FDA 21 CFR Part 11 and EU Annex 11 compliant data storage that's affordable and easy to use. In combination with an overall laboratory compliance plan, an ICP-MS MassHunter system with OpenLAB Data Store for MS provides controls needed to follow regulatory guidelines."