Thermo launches GLP-compliant interface
interface that promotes compliance with Good Laboratory Practice
(GLP) standards and 21 CFR Part 11 electronic records keeping
regulations.
The interface links Thermo's Watson Laboratory Information Management System (LIMS) and it's Xcalibur mass spectroscopy (MS) software. It is made possible by an XML-based instrument gateway, which facilitates data transfer between the LIMS and the MS instrument control software.
The Watson LIMS is specifically designed to support drug metabolism and pharmacokinetic (DMPK) studies in drug development. The system communicates with external software from instruments such as LC/MS, ICP-MS, HPLC and other systems via file-based and digital interfaces.
"The bi-directional digital interface ensures the transfer of analytical run information directly from Watson to Xcalibur and the return of results back to Watson without an intermediate file," said Joel Usansky, product manager for Watson LIMS.
Traditional file-based interfaces involve importing a LIMS-generated sequence file into an instrument control software system like Xcalibur, and then a results file back into a LIMS. That means text files have the potential to be lost, misplaced or changed, which exposes a laboratory to possible non-compliance with GLP or 21 CFR Part 11 regulations.
"Thermo software solutions eliminates the need to import text files, and therefore improves laboratory efficiency," he added.
The Watson LIMS 7.2 release, developed to support Oracle 10g, includes numerous enhancements, including study sign-off, custom study fields, and analysis of solutions and preparations.
The system communicates with external software from instruments such as LC/MS, ICP-MS, HPLC and other systems via file-based and digital interfaces.
The Xcalibur software is a Windows-based data system, providing instrument control and data analysis for the entire family of Thermo's mass spectrometers including the Finnigan TSQ Quantum triple quadrupole mass spectrometer series. Xcalibur enables acquisition and processing of data as well as results delivery.
Thermo has been boosting its presence in LIMS since developing its in-house Nautilus system a few years back, in a bid to gain a leadership position in a sector tipped to grow by around 4.8 per cent per annum over the next five years, reaching $366 million in 2008, according to a report published last year by Arc Advisory Group.
