Thermo Fisher Scientific Introduces New Functionality in its Purpose-Built Darwin LIMS for Pharmaceutical Manufacturing R&D and QA/QC

Thermo Fisher Scientific Inc., the world leader in serving science, today introduced significant functionality enhancements to Darwin LIMS™, its purpose-built Laboratory Information Management System (LIMS) designed specifically for pharmaceutical manufacturing R&D and QA/QC. Already offering dissolution, stability management, product and batch management, environmental monitoring and system interfacing, Thermo Scientific Darwin 3.0 brings new capabilities to pharmaceutical labs.

Darwin 3.0’s new fully validated web interface allows for more efficient reporting and sharing of test data across the lab. Built on the Microsoft .NET framework, Darwin can easily be extended to include dashboard-ready tools for multi-user and multi-site environments where the interface gives immediate information on resource and instrument utilization so laboratory managers can maximize productivity by optimizing resources.

Darwin 3.0 also features solution and reagent inventory management and built-in instrument calibration and maintenance, allowing continuous operations and increased efficiencies. Reagent lots and amounts are logged and tracked over time, ensuring that a test is never stopped due to lack of reagent availability or a bad/expired lot. Likewise, instrument calibration and maintenance tracking prevents a user from running a test on an uncalibrated or out of compliance instrument. “Building this functionality into the core Darwin product provides organizations with the assurance that they are fully compliant and meeting regulatory requirements at all times,” said Gary Walz, Darwin Product Manager, Thermo Fisher Scientific.

Pharmaceutical labs will realize a lower total cost of ownership due to Darwin’s user-friendly and intuitive interface, as well as the industry-specific functionality that is built into the product, reducing the need for costly customization to standardize processes. The product was designed and optimized to operate on the Oracle 10g platform, with extensive interfacing capabilities to provide tight integration with SAP for rapid batch disposition and release and streamlined workflow, plus new historical data trending and charting functionality. The embedded charting and trending for product stability testing allows for real-time data review and rapid reporting. By incorporating SAP and additional systems interfacing capabilities, as well as batch and product management capabilities, customers are better prepared to integrate Darwin into their global enterprise landscape.

"Our goal with Darwin has been to deliver as much domain-specific, out-of-the-box functionality to our customers as possible. Version 3.0 addresses not only the critical needs of the pharmaceutical laboratory, but also brings with it the increased functionality multi-site/multi-user labs are looking for. These new features clearly position Darwin as the definitive solution for the pharmaceutical industry. Darwin lowers the cost, risk and time associated with implementation, training, validation, maintenance and upgrades compared to generic LIMS that require costly customizations,” says Dave Champagne, vice president and general manager for Informatics, Thermo Fisher Scientific.

The newest features built into the latest release of Darwin have been designed to meet FDA regulations, and brings pharmaceutical labs time savings in validation efforts, and cost savings in personnel and production time. Darwin 3.0, with its built-in dashboard ready functionality, will allow pharmaceutical lab managers to make faster decisions and, with reduced validation time, bring their drugs to market sooner.

For more information about Thermo Scientific informatics solutions visit the company website.