Tecan is a leading global provider of laboratory instruments and solutions in biopharmaceuticals, forensics, and clinical diagnostics. The company specializes in the development, production, and distribution of instruments and automated workflow solutions for laboratories in the life sciences sector.
Novartis markets products that test for the presence of HIV, HIV-1/HCV, HBV, and West Nile Virus in blood donated to the Red Cross and centers around the world.
Project: Documentation and Verification of Blood Bank Software Application.
- Partner with Tecan to create an automated blood pooling system with a customized software application that will integrate easily with Novartis Corporation’s blood bank screening technology and process.
- Provide language localization for European and South American markets.
- Deliver airtight documentation and software verificationto allow for an FDA 510(k) medical device submission.
- Worked closely with Tecan engineers and the Novartis product team to develop a pooling system software application.
- Delivered full documentation of development and verification testing.
- Helped Novartis achieve FDA 510(k) clearance of CPT Pooling Software application.
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 three plus years of 24/7 usage of the CPT 3.0 software on more than 100 pooling systems worldwide, 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.”
—Senior Software Architect, Tecan