“After extensive review of technical support and field reports to find potential issues to resolve with the revision of software, our client did not find a single issue. In the last 3 plus years of 24x7 usage of the CPT 3.0 software on more than 100 pooling systems world-wide, there has never been a reported bug. Obviously, we, and in particular Code Refinery’s documentation and testing effort, did something extraordinarily right! Code Refinery did a great job."

Chiron Corporation (A Novartis business) markets products which test for the presence of HIV, HIV-1/HCV, HBV and West Nile Virus in blood and plasma donated to the Red Cross and blood centers around the world.

The automated system needed to easily integrate with Chiron’s screening technology and process and provide localization for European and South American markets. The documentation package needed to be air tight to allow for an FDA 510(k) device submission and satisfy FDA CBER regulations.

Code Refinery worked closely with Tecan engineers and the Chiron product team to develop Chiron’s pooling software application. We developed meticulous documentation and performed verification testing which was carried out in two shifts in order to meet schedule deadlines. Chiron was granted FDA 510(k) approval of CPT Pooling Software application (BK040058). Code Refinery continues to partner closely with Tecan and Chiron to deliver new products as well as enhancements to existing blood banking products.