Thermo Scientific - Darwin LIMS

Manufactured by  Thermo Scientific
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Allows R&D and production data to be logically organized, summarized and reported.

Thermo Scientific* Darwin LIMS is designed with purpose-built functionality that gives managers the data they need to make the most cost effective decisions that ensure regulatory compliance and the safety of their product.

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 our helpdesk, Darwin provides 'out of the box' nearly everything pharmaceutical manufacturing labs need, and nothing they don't.

As pharmaceutical companies face increasing pressures to bring their drugs to market faster and to find the next blockbuster, they need to access more and more information from their production process in order to make essential and timely decisions. Add to this pressure the continuous cost constraints every pharmaceutical company is facing and it becomes even more critical for manufacturing operations to have immediate access to their sample management, audit trails, environmental monitoring and stability test data.
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Features of Darwin LIMS

Pharmaceutical Manufacturing R&D

  • Used by both R&D and QC—no requirement to manually transfer product information from an R&D LIMS to a QC LIMS
  • Batch and product-orientation allows R&D data to be more easily stored, summarized and reported
  • Regulates compliance requirements based on the type of data being manipulated—enables flexible approach for R&D

Pharmaceutical QA/QC

  • Provides complete testing solutions within the core feature set
  • Embeds standard business logic to accelerate decision-making
  • Incorporates notification tools to improve communications
  • Accomodates variety of study designs
  • Study data which can quickly summarized for reporting
  • Tracks batch hierarchy and genealogy—enabling batch/lot release testing results to be associated with final product
  • Environmental monitoring, essential for product quality and compliance—includes test allocations for monitoring sampling points and frequency of collection

Business Benefits

  • Standardization of company process lowers total cost of ownership
  • User-friendly, intuitive interface ensures end-user acceptance and support for process modification as part of standardization
  • Allows maximized use of common functionality and eliminates or reduces customization—in the instances where customization is necessary, Darwin uses standard programming tools like Microsoft Visual Studio .NET
  • No proprietary programming or scripting languages

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
  • Enable standardization—solid foundation for multi-site harmonization Lower total cost of ownership while improving productivity and end-user experience

Recommended for:

  • Dissolution (single-point and multi-point)
  • Environmental monitoring
  • Stability management
  • Product management
  • Batch management
  • System interfacing
General Specifications

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