Purpose-Built LIMS for Pharmaceutical Manufacturing Makes European Debut at Analytica 2006
22 May 2006Thermo 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.
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Darwin
Thermo Fisher ScientificDarwin LIMS is specifically designed to address the unique needs of pharmaceutical manufacturing R&D and QA/QC labs. Darwin's unique batch and product oriented design aligns directly with pharmaceutical manufacturing processes, allowing R&D and production data to be logically organized, summarized and reported. By including industry specific standard functionality that is directly supported by Thermo's helpdesk, Darwin provides – out of the box – nearly everything pharmaceutical manufacturing labs need, and nothing they don't. The unpredictable costs and risks associated with customizing a traditional Laboratory Information Management System to serve the needs of pharmaceutical manufacturing are giving rise to the trend toward application-specific, commercial off-the-shelf (COTS) software solutions. Darwin LIMS meets pharmaceutical-specific requirements as a standard commercial solution. Among Darwin’s industry-specific functionality, which are covered in the user manual and supported by the helpdesk, the system handles: Dissolution (Single-point and Multi-point) Content Uniformity Stability Management Product Management Batch Management System Interfacing Pharmaceutical Manufacturing R&DBecause Darwin can be used by both R&D and QC, there is no need to manually transfer product R&D to QC. Darwin’s batch- and product-orientation allow R&D data to be more easily stored, summarized and reported than sample-only systems. And while meeting the rigid compliance requirements of QC, Darwin regulates compliance requirements based on the type of data being manipulated – enabling a more flexible approach for R&D while within the same application.Pharmaceutical QA/QCIn addition to providing complete testing solutions within the core feature set, Darwin embeds standard business logic to accelerate decision-making and incorporates notification tools to improve communications. The solution’s stability management tools accommodate a variety of study designs, and study data can be quickly summarized for reporting. Darwin also tracks batch hierarchy and genealogy, enabling batch/lot release testing results to be associated with final product.Business benefitsLowering total cost of ownership is more easily achieved with Darwin, when used to standardize company processes. A user-friendly and intuitive interface ensures end-user acceptance and support for process modification as part of standardization. Lab managers can maximize use of common functionality and eliminate or reduce customization by deploying Darwin. In the instances where customization is necessary, Darwin uses standard programming tools like Microsoft® Visual Studio .NET, not proprietary programming or scripting languages.Darwin is designed to:Support the product entity – batches and specifications are tied to correct product Handle complex study designs – supporting and shortening time to define protocols Track inventory, provide notification – reducing risk of protocol deviations Easily filter, sort and report data – users rapidly summarize and report data without IT intervention Embed multi-stage test logic – for complex aggregate tests like dissolution and content uniformity Enable standardization – solid foundation for multi-site harmonization Lower total cost of ownership while improving productivity and end-user experience