Thermo Introduces New Free-Of-Charge Darwin LIMS Datasheet for Pharmaceutical Manufacturing

13 Jan 2006

Thermo Electron Corporation, the world leader in Laboratory Information Management Systems (LIMS), has developed a new datasheet to provide an overview of the capabilities of its newly launched Commercial-Off-The-Shelf (COTS) software solution, Darwin LIMS™.

This comprehensive document is of particular interest to scientists working in Pharmaceutical R&D and Manufacturing Quality Control (QC) laboratories.

Thermo’s new datasheet is entitled “DARWIN LIMS™ –Information Management for Pharmaceutical R&D and Manufacturing QC”. It discusses the unique challenges facing the pharmaceutical industry regarding regulatory compliance, complex testing and batch-centric, non-continuous manufacturing processes. It then builds a case for employing COTS solutions instead of generic LIMS to avoid lengthy, costly customization projects.

The new Darwin LIMS datasheet also provides an overview of the software’s data processing capabilities. Darwin is able to seamlessly integrate into pharmaceutical manufacturing organizations and interface not only with database systems such as SAP, but also allow interactions with other data treatment applications.

Darwin has been developed by Thermo to lower the risks and reduce the time associated with implementations as well as the Total Cost of Ownership (TCO) of modern LIMS solutions. Darwin fulfills many customer requirements “out-of-the-box” by providing deeper, more targeted pharmaceutical functionality compared to traditional LIMS. Dissolution, content uniformity, stability, product and batch management and system interfacing are dedicated capabilities within Darwin.

This new datasheet is available free of charge to all laboratory managers in hard copy format or as a downloadable pdf. To obtain a free-of-charge copy of the new datasheet, simply download it in pdf format from www.thermo.com/lims or order a copy via marketing.informatics@thermo.com

Darwin

Thermo Fisher Scientific

Darwin 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

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Thermo Introduces New Free-Of-Charge Darwin LIMS Datasheet for Pharmaceutical Manufacturing