Waters Corporation has announced that Arista Laboratories in the US has purchased its NuGenesis Scientific Data Management System (SDMS) software in order to become the first such laboratory to offer GLP testing.
This will help the company to adhere to the 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 by June end.
Good Laboratory Practices are well-established regulations issued by the US 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. In this regard, Arista Laboratories intends to become the first contract laboratory to offer GLP testing of tobacco products in anticipation of new FDA regulations.
Arista is preparing to provide GLP services in connection with the Tobacco Control Act signed into law by President Obama in June, 2009. The legislation gives the US Food and Drug Administration new authority to regulate tobacco products which could include new GLP requirements for laboratories.
The company did not want to wait until the last minute to prepare for meeting the reporting timetables. “We need to have our systems in place beforehand,” said Brad Norwood, director, Arista Laboratory.
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. “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,” stated Randy Courington, business development manager, Arista.
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 II 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. The software has also proven to increase productivity and, combined with its single point of access for all information regardless of geography, and has also resulted in cost efficiency, according to officials from Waters.