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Achieve compliant ICP-MS data management with new OpenLAB Data Store for MS

By Linda Doherty
Agilent Product Manager for OpenLAB Data Management Solutions

While the USP <232>/<233> general chapters on testing for inorganic impurities in pharmaceutical products and ingredients have not yet been ratified, laboratories preparing to implement these new methods need a secure central storage solution for their ICP-MS data. Smaller inorganic laboratories, in particular, need a solution that is affordable, easy-to-deploy and easy-to-use.

That’s why Agilent developed OpenLAB Data Store for MS. It’s a simple and cost-effective networked solution for the compliant storage of data acquired with Agilent ICP-MS MassHunter Workstation software.

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Figure 1. In combination with SOPs that provide an overall compliance plan, a system that includes MassHunter, User Access Control Software and OpenLAB Data Store for MS delivers the controls needed to achieve compliant ICP-MS data management.

A compliance solution for smaller labs running inorganic analyses

Agilent OpenLAB Data Store for MS is a networked solution designed for smaller laboratories and is scalable for up to fifteen Agilent ICP-MS systems. An ICP-MS with MassHunter and OpenLAB Data Store for MS (as shown in Figure 1) adds the controls needed to meet USP <232>/<233> and US FDA 21 CFR Part 11 and EU Annex 11 requirements and – when combined with SOPs – provides an overall compliance plan. The OpenLAB Data Store for MS bundle allows labs to grow their compliant data storage capacity to include an additional ICP-MS system at a price that is less than two standalone secure workstations.

Manage and secure data when integrated with ICP-MS MassHunter software

OpenLAB Data Store for MS integrates with Agilent’s ICP-MS MassHunter Workstation and User Access Control (UAC) software to provide the capabilities that labs need to manage and secure their ICP-MS data – including storage, search, access control, audit trail and e-signature authorization. All data and reports are stored during the analytical run in a secure data repository, automatically and without user intervention.

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Figure 2. User access to the ICP-MS MassHunter Workstation and audit trails is managed using the MassHunter UAC software.

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Figure 3. MassHunter UAC software records user actions in the audit trail for easy review with full traceability.

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Figure 4. Using OpenLAB Data Store for MS, any ICP-MS MassHunter file or document can be searched and retrieved, quickly and easily.

Account management streamlines data security

Data is secured through controlled access to files in Agilent OpenLAB Data Store. MassHunter functions are configured by the system administrator in the MassHunter UAC (Figure 2).

Login with an authenticated user ID and password is mandatory. Users log-on to the ICP-MS MassHunter Workstation and operate the ICP-MS MassHunter software in exactly the same way as they would a standalone system, but they are restricted to their level of user access rights.

Readily traceable audit trail provides easy review

Agilent Open LAB Data Store for MS captures, tracks, and secures all files including master methods, sequences, and reports with a complete revision history and audit trail. The audit trail records any changes, and stores those updates as revisions for easy review with complete traceability (Figure 3). These capabilities can dramatically reduce the time spent collating information for an investigation.

Data and documents are easy to store, find, and share

Data stored in the OpenLAB Data Store for MS are easy to find and retrieve using keyword searching (Figure 4). When files are uploaded to OpenLAB Data Store, the software automatically extracts and indexes relevant information, such as sample name, operator or instrument name, which expedites future data retrieval. Since searches are powered by a state-of-the-art search engine, results retrieval is remarkably fast.

Another OpenLAB product designed to streamline information management

Agilent OpenLAB Data Store for MS is part of the industry-leading OpenLAB Software Suite of software products that is designed to integrate and manage scientific information throughout its lifecycle, across the laboratory and the enterprise. It complements Agilent’s OpenLAB Enterprise Content Manager (ECM) software for the compliant management of multi-vendor, multi-instrument technique data in larger laboratories.

Ready to deploy for immediate productivity gains

If you are searching for an affordable, straightforward solution to facilitate compliant management of your ICP-MS MassHunter data, Agilent OpenLAB Data Store for MS is the answer. Because the software is designed to work at installation without customization, you can expect to be up and running in as little as two days. Learn more today about how your laboratory can take advantage of Agilent OpenLAB Data Store for MS.

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