Version 3.0 of the system, which was launched this month, features a new fully validated web interface built on the Microsoft .NET framework, which the firm claims will improve data sharing tracking and reporting.
Dave Champagne, vice president and general manager of Thermo Fisher’s Informatics operations told in-PharmaTechnologist that: “Darwin has been adopted including pharmaceutical company globally, being installed in major pharmaceutical companies based in North and South America, and China.
“These include Eurofarma in Sao Paulo Brazil which is the third largest pharmaceutical company in Brazil specializing in the manufacture of drugs for human and veterinary use." He added that Eurofarma has selected Darwin to increase lab productivity while ensuring compliance with regulatory requirements.
Champagne explained that “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.”
He added that in contrast with rival systems that separate environmental monitoring and LIMS processes, Darwin 3.0 integrates “an environmental monitoring module as standard, facilitating product quality monitoring and compliance.”
Champagne also stressed that the system is specifically tailored for pharmaceutical manufacturing industry in terms of its compliance with US Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) production rules.