Code Refinery Success Stories
















Chiron Corporation

Business Challenge

Chiron, a major supplier to the blood banking market combined their blood testing products with automated liquid handlers. Their vision required:

  1. Custom software
  2. A liquid handler to automate the blood pooling work function in blood banks
  3. 510k achievement


Outcome

Code Refinery partnered with Tecan US to develop software under a formal development life cycle. They created the necessary software documentation and completed and executed the necessary design and review activities and software validation for the system.

Chiron was granted a 510k from the FDA for their system.

+ Chiron Case Study

Key Features and Benefits

Reduced in-house labor: Code Refinery’s software validation resulted in less in-house validation required by Chiron

Broadened software language base: Software localization for European and South American languages

Achieved compliance: 21 CFR Part 11 compliance implemented and validated



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