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 organised, summarised 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.
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
- 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 summarised 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
- 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 standardisation
- Allows maximised use of common functionality and eliminates or reduces customisation—in the instances where customisation is necessary, Darwin uses standard programming tools like Microsoft Visual Studio .NET
- No proprietary programming or scripting languages
- 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 summarise and report data without IT intervention
- Embed multi-stage test logic—for complex aggregate tests like dissolution
- Enable standardisation—solid foundation for multi-site harmonisation
- Lower total cost of ownership while improving productivity and end-user experience
- Dissolution (single-point and multi-point)
- Environmental monitoring
- Stability management
- Product management
- Batch management
- System interfacing
For more information, please see our website.