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COTS: What does Darwin mean for the Pharmaceutical Industry?
The generic design approach has long meant that for a LIMS to meet the specific business needs of any industry, extensive customisation is required.  Unfortunately for customers, such customisation is commonly only possible through the use of proprietary programming languages. The combination of minimal industry specific functionality and often out-dated proprietary languages has been particularly troublesome in the pharmaceutical industry.

Despite the fact that pharmaceutical testing processes are quite well standardized in national pharmacopoeias, and that the regulations governing pharmaceutical manufacturing are consistent and broadly applied, no LIMS has ever sought to incorporate these testing methods or regulations in a solution specifically designed for the pharmaceutical industry. LIMS implementations at pharmaceutical companies have been, almost without exception, long, costly and painful processes involving extensive customisation.

The effect of such highly unique deployments is not restricted to the deployment. Customers commonly create their own user documentation, design documentation, validation scripts, and help files, and incur enormous costs simply supporting the system over the years.

Darwin redefines the LIMS marketplace.

Darwin is a Commercial of The Shelf (COTS) LIMS that has been built to support standards found in the pharmaceutical industry. It's design concepts are familiar to pharmaceutical companies and users, offering an intuitive user interface and a logical layout that includes common objects like batches, drug products, drug substances, and market based specifications, as well as standard testing methods like assays and dissolution testing. Darwin is developed on the Microsoft .NET framework, supporting open development standards so that in cases where specialized functionality is required, users can extend the system using standard commercial development tools and languages.

Darwin gives the users what they need, faster.