Purpose-Built LIMS for Pharmaceutical Manufacturing Makes European Debut at Analytica 2006

Thermo Electron Corporation has introduced Darwin LIMS™, Thermo’s latest purpose-built laboratory information management system (LIMS).

Making its European commercial debut at Analytica, Darwin is designed as a commercial-off-the-shelf (COTS) solution specifically for pharmaceutical manufacturing R&D and QA/QC – lowering the total cost of ownership by delivering a far greater proportion of required functionality as standard.

A natural selection for the world’s leading pharmaceutical companies, Darwin has been developed to lower the cost, risk and time associated with LIMS implementations. It has been designed to fulfill as much as 85 percent of a typical customer’s requirements “out-of-the-box” by providing deeper, more targeted pharmaceutical functionality compared to traditional LIMS. Generic LIMS meet approximately 30 percent to 40 percent of requirements, and then undergo lengthy, costly and often risky customizations to deliver a system that meets the customers’ needs.

In Darwin, users will find dissolution, content uniformity, stability management, product management, batch management and system interfacing as dedicated capabilities – fully supported by Thermo’s helpdesk and covered in depth in the user manual. In addition, there are some 15 pre-configured libraries built specifically for pharmaceutical R&D and QA/QC, and the software provides templates to maintain compliance with several regulatory agencies worldwide, including the International Conference on Harmonization (ICH). The inclusion of such functionality and industry workflows as standard in the base system significantly reduces on-site customization, resulting in reduced costs, risks and time associated with implementation, training, validation, maintenance and upgrades.

Another advantage is that Darwin is not limited to a restrictive sample-centric workflow. Darwin’s product- and batch-oriented workflows allow R&D and production data to be logically organized, summarized and reported, allowing users to work more effectively and providing managers with a broad view of the entire manufacturing process.

Darwin has been created using the Microsoft® .NET framework. This enables users to extend the system using industry standard tools, not a proprietary language that the vendor must teach key users of the system how to program.

As the leading provider of analytical instruments, equipment, robotics, software and services to these industries, Thermo’s exhibit will feature laboratory information management systems (LIMS) and chromatography data systems (CDS) that integrate not only with Thermo’s products for an end-to-end solution, but with the customers’ enterprise to yield increased productivity and greater knowledge from laboratory data. Thermo’s informatics focus is to offer COTS software that reduces reliance on costly and risky customizations.