SubscribeCarboGen and AMCIS will extend the application of their state-of-the-art Laboratory Information Management System (LIMS) to include late-phase clinical and commercial projects at their site in Bubendorf, Switzerland.
The pharmaceutical services provider will also install a Chromatographic Data Management System (CDS) at the Bubendorf site.
As part of the upgrade, the system will be configured to manage all stages of analytical work from early development through the release of commercial products. It will allow customers real-time access to release data for each of their active pharmaceutical ingredients (APIs) and intermediates and complementary regulatory analytical measurements, such as stability studies.
"The expansion of LIMS and CDS technology will provide greater automation, improved lab data management and seamless analytical knowledge management throughout all of the sites in our system," said Franz Breitfield, manager of analytical development for CarboGen and AMCIS. "The increased productivity, efficiency and quality that result will improve our ability to help customers get new drugs to market with reduced time, cost and risk."
The upgraded system will offer expanded usability with more intuitive navigation of LIMS and greater ability to access analytical and release data via a customer portal. "Since implementing LIMS in 2002, we have been extremely pleased with the paper-free work processes that have resulted," said Alan Fischer, divisional head of information technology for CarboGen and AMCIS. "A secure internet portal allows customers to access their projects, from raw HPLC data, to the release information of their shipped API products."
In 2002, CarboGen and AMCIS implemented LIMS at two other sites, Aarau and Neuland, so the Bubendorf upgrade means LIMS will be active throughout the entire organization. LIMS complies in full with 21 CFR part 11 requirements. The upgrade is scheduled to run throughout 2006 into 2007.