MILFORD, Mass., May 13, 2011 /PRNewswire via COMTEX/ -- Waters Corporation (NYSE: WAT) announced today that Arista Laboratories (Richmond, VA) has purchased the Waters NuGenesis® Scientific Data Management System (SDMS) software in order to become the first such laboratory to offer GLP testing of tobacco products in anticipation of new FDA regulations which may require the analysis and reporting of identified harmful constituents. Arista is targeting completion for the implementation of its new enterprise software in the first half of this year.
Good Laboratory Practices (GLPs) are well-established regulations issued by the U.S. Food and Drug Administration in regulated pharmaceutical and food testing laboratories which specify, among other things, how laboratories must secure records and manage and archive test data.
Arista is preparing to provide GLP services in connection with the Tobacco Control Act signed into law by President Obama in June of 2009. The legislation gives the U.S. Food and Drug Administration new authority to regulate tobacco products which could include new GLP requirements for laboratories.
"If you wait until the last minute, there is a strong likelihood that you will not be able to meet the reporting timetables. You need to have your systems in place beforehand," said Arista Laboratory Director Brad Norwood.
Arista Laboratories has recently expanded its portfolio and performs analytical and toxicology work for a growing list of clients and currently follows ISO 17025 quality control standards.
If GLP requirements are put into place as part of the regulatory framework, Arista wants to be ready. Says Arista Business Development Manager Randy Courington, "We made a decision that we would prepare ourselves knowing that changes are likely. If nothing changes, we will at least be ahead of the curve and have the capability to take on projects under GLP."
Following GLP means, among other obligations, adhering to strict recordkeeping requirements.
Says Courington, "Documentation is key. If you haven't got it written down somewhere, it didn't happen. You have to be able to lay your hands on any information at any time; you can't rely on memory, you need to have firm proof: here's the record, here's exactly what happened."
A Waters customer since 2003, Arista presently uses Waters® ACQUITY® UltraPerformance LC (UPLC®) and HPLC systems on a Waters Empower(TM) chromatography data system network, and a Waters triple quadrupole mass spectrometer running on Waters MassLynx(TM) mass spectrometry software.
The NuGenesis SDMS is an automated electronic repository that stores and manages all types of scientific data to a centralized database, offering excellent integration with a multitude of research applications. Many leading pharmaceutical, biotechnology and chemical/industrial companies have standardized on SDMS because it can accelerate research, improve scientific collaboration, preserve data for the long term, and provide documentation and protection for intellectual property and 21 CFR Part 11 compliance. Using automated "file and print capture" technology, SDMS captures and stores the critical scientific data generated by any instrument or application. All data is automatically made searchable using advanced functionalities.
NuGenesis SDMS has proven to increase productivity and, combined with its single point of access for all information regardless of geography, has resulted in a substantial reduction in operational costs.
For more information on NuGenesis SDMS 7.1 please visit: http://www.waters.com/waters/nav.htm?cid=10067099
About Arista Laboratories (www.aristalabs.com)
Arista Laboratories is an ISO 17025 accredited, analytical testing organization designed to meet the regulatory-driven demand for the evaluation of tobacco constituents and smoke emissions. Operating as an independent laboratory, Arista is able to deliver objective third party analyses for compliance, research and development, and product stewardship. In 2009, Arista made the commitment to begin migrating towards current Good Laboratory Practice (cGLP).
With the implementation and validation of this software and qualification of its instrumentation, Arista intends to be fully compliant with 21 CFR Part 11 and 21 CFR Part 58 guidelines thus ensuring adherence to cGLP.
Arista Laboratories, Inc. and Arista Laboratories Europe are wholly owned businesses of Molins PLC.
About Waters Corporation (www.waters.com)
For over 50 years, Waters Corporation (NYSE: WAT) has created business advantages for laboratory-dependent organizations by delivering practical and sustainable innovation to enable significant advancements in such areas as healthcare delivery, environmental management, food safety, and water quality worldwide.
Pioneering a connected portfolio of separations science, laboratory information management, mass spectrometry and thermal analysis, Waters technology breakthroughs and laboratory solutions provide an enduring platform for customer success.
With revenue of $1.64 billion in 2010 and 5,400 employees, Waters is driving scientific discovery and operational excellence for customers worldwide.
Waters, UPLC, NuGenesis, Empower and MassLynx are trademarks of Waters Corporation.
SOURCE: Waters Corporation