Just two months ago, Thermo Fisher Scientific introduced version 2.0 of its Darwin laboratory information management system (LIMS), noting significant improvements over the first purpose-built system introduced last year.
APP has picked up on these features and will deploy Darwin LIMS for pharmaceutical manufacturing R&D and QA/QC in each of its three manufacturing facilities located in New York, Illinois and Puerto Rico.
The multi-phase project will initially involve the deployment of Darwin’s environmental monitoring functionality, which will enable facilities to move from manual systems onto an automated system for microbiological samples from the sterile manufacturing environment.
The second phase of the project will feature an integrated LIMS and Chromatography Data System (CDS) implementation followed by the third phase of the LIMS rollout including SAP interfaces across all sites.
Thermo Scientific Darwin LIMS is a purpose-built LIMS for pharmaceutical manufacturing R&D and QA/QC laboratories. Since it contains an Environmental Monitoring module as standard, implementation and validation time and costs are greatly reduced versus generic LIMS. Environmental monitoring is essential for product monitoring and compliance. Thermo Scientific Atlas CDS is a GLP and 21 CFR Part 11 compliant enterprise CDS. Atlas CDS provides comprehensive multiple vendor instrument control.
In addition to environmental monitoring, Darwin 2.0 features several other improvements. The reporting engine, Retriever, has been enhanced. A web-based data enterprise reporting solution, it features dashboard management that enables Darwin users to measure and forecast key performance indicators in real time. Retriever allows data from any informatics systems, current or legacy, to be directly and securely accessed by the appropriate people within the organization. Also new in Darwin 2.0: support for the creation and management of inspection lots via a tight integration with SAP; enhanced instrument management; a formula builder to define complex components limits; support for test allocations; and improvements to the review and approval process that make it easier and faster for users.
