“Thank you for the successful development, validation and implementation of the “Install Software” for the Baxter 3D Pooling software on Windows XP for the recovered plasma pooling project. The staff at Code Refinery exceeded my expectations as far as the documentation, validation, support and timeliness of project.”
— Senior Manager, Regulatory Licensing, Baxter/BioLife Plasma Services





Case Study

Upgrading computer operating system of FDA cleared plasma screening systems extends service while minimizing impact to production and cost.

CHALLENGE

Migrate pooling software application to run under the Windows XP operating system for an FDA licensed automated plasma pooling system. The automated pooling system is a critical component in the screening of plasma donations used to produce life saving therapies. The upgrade must minimize impact to screening and maintain FDA compliance.

RESULTS DELIVERED

Code Refinery developed a customized installer which centralized installation of the 3-D pooling software application and automated post installation steps . The upgrade was implemented without any code changes to the licensed 3-D pooling software. This allowed verification testing to focus on operating system migration and custom installer.

We accelerated the schedule and minimized cost by reusing existing test cases for the current version of the pooling software for functional test execution. A complete set of life cycle documentation was developed for the project which also aided in maintaining FDA compliance.

CONFIDENTIAL: The information presented is considered the property of Code Refinery, LLC and has been prepared on a confidential basis solely for the benefit of selected individuals and institutions.
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