Thermo Fisher Scientific has announced that its Darwin Lims has been installed and fully validated at Eurofarma.
Eurofarma is the third largest pharmaceutical company in Brazil, specialising in the manufacture of drugs for human and veterinary use.
Thermo Scientific Darwin Lims was selected by Eurofarma to standardise processes across its multi-laboratory infrastructure, automate its operations and consolidate data management across its manufacturing facilities in a single Lims.
The installation of Darwin Lims will help contain costs and improve efficiencies as Eurofarma continues to grow in South America's competitive pharmaceutical environment.
Osvaldo Orellana of Eurofarma said: 'Eurofarma has selected Darwin Lims because it will increase the lab productivity while ensuring compliance with regulatory requirements.
'We expect Darwin Lims to accelerate our decision-making processes by improving internal communications, which will help facilitate our flexible approach to research and development activities while maintaining the rigid compliance requirements of our quality control activities.' Thermo Scientific Darwin Lims is specifically designed to address the needs of pharmaceutical manufacturing research and development (RandD) and quality assurance/quality control labs.
It will also help Eurofarma meet FDA regulations, bring significant time savings in validation efforts, and create cost savings in personnel and production time.
Darwin's batch and product-oriented design aligns directly with pharmaceutical manufacturing processes, allowing RandD and production data to be logically organised, summarised and reported.
Darwin Lims also includes built-in, dashboard-ready functionality to allow pharmaceutical lab managers to make faster, more informed decisions.
The project also included the installation of Thermo Scientific Atlas CDS, the enterprise-level chromatography data system.
The system controls hundreds of instruments from a variety of vendors in compliance with FDA regulations, including 21 CFR Part 11.
Atlas was developed in partnership with leading chromatographers to configure to any laboratory's workflow, while providing the flexibility to integrate with Lims and other enterprise-level data management systems.
