Thermo Fisher Scientific Introduces Darwin LIMS 3.0 with Enhanced Functionality for Pharmaceutical Applications

Thermo Fisher Scientific Inc., the world leader in serving science, today announced significant functionality enhancements to Darwin LIMS™, its purpose-built laboratory information management system (LIMS) designed specifically for pharmaceutical QA/QC. Offering environmental monitoring, dissolution, stability management, product and batch management and system interfacing, Thermo Scientific Darwin 3.0 brings new capabilities to pharmaceutical laboratories. The enhanced LIMS will be showcased at the Thermo Scientific booth 1741 at PITTCON 2008, being held March 3 – 6 in New Orleans.

Until now, environmental monitoring and LIMS have typically been disparate systems, requiring users to monitor and aggregate data from multiple environmental locations for product and batch traceability. Thermo Scientific Darwin LIMS fully integrates environmental monitoring data into the batch record. Built-in charting tools allow users to visualize each location independent of the samples. This ensures that any failure is apparent at the batch level and allows the laboratory to quickly determine whether the source of the contamination is in the laboratory or the production environment. This embedded functionality enables laboratory managers to react rapidly to non-conforming product before it reaches the consumer.

“By linking this data to the LIMS directly, pharmaceutical companies using Darwin can have greater confidence in the quality of their results and, ultimately, in the quality of the product they bring to the consumer,” said Dave Champagne, vice president and general manager for informatics products, Thermo Fisher Scientific. “We believe no other LIMS vendor can offer the scope, breadth and depth our solution delivers.”

The new fully validated Web interface of Darwin 3.0 allows for more efficient reporting and sharing of test data across the laboratory. Built on the Microsoft .NET framework, Thermo Scientific Darwin can be easily extended to meet the specific needs of a customer to include dashboard-ready tools for multi-user and multi-site environments. 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 prevent a user from running a test on a non-calibrated or out-of-compliance instrument. “Building this functionality into the core Thermo Scientific 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.

With its friendly and intuitive user interface and built-in industry-specific functionality, pharmaceutical laboratories using Darwin will avoid costly customizations to standardize processes and realize lower total cost of ownership for their LIMS. Thermo Fisher designed and optimized the product to operate on the Oracle 10g platform, and it offers extensive interfacing capabilities to provide tight integration with SAP for rapid batch disposition and release and streamlined workflow. 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. Darwin also provides historical data trending and charting functionality. The embedded charting and trending for product stability testing allows for real-time data review and rapid reporting.

“Our goal with Darwin has been to deliver as much domain-specific, out-of-the-box functionality to our customers as possible,” added Champagne. “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.”

The newest features built into the latest release of Darwin were designed to help customers meet FDA regulations, while simultaneously saving them time in validation efforts and reducing personnel costs and production time within pharmaceutical laboratories. Darwin 3.0, with its built-in dashboard-ready functionality, will allow pharmaceutical operations managers to make more rapid decisions, reduce validation time and ensure that quality drugs are produced faster.