“I'm very pleased with Code Refinery and the response from your company when we came upon a problem with software installation. The issue was addressed and resolved promptly. I felt that there was open communication between us to get the problem resolved quickly.”

ISBT 128 sets the global standard for identification, labeling and information processing of human blood, tissue and organ products. This standard needed to be implemented in blood screening assay systems manufactured by Gen-Probe who is a global leader in the development and manufacture of these assay products. ISBT 128 support needed to be implemented in existing FDA approved software for assay products used to screen for HIV-1, HCV, HBV and West Nile viruses in donated blood.

Code Refinery implemented ISBT 128 support in the required software for the blood screening assay products. Full documentation of all development and verification activities was generated to maitian compliance with FDA regulations for software used in blood banks. The software release candidate for software and final documentation was delivered ahead of schedule.