Yoshimi Yancey helps companies set up Computer System Validation programs and facilitate client, FDA, and EMA audits. Computer System Validation is the process of documenting that a computer system meets a set of defined requirements. It is a mandatory requirement as dictated by US and European regulations for any of the following types of systems: Medical Device Software, Production Software, Quality Management Software, Software holding FDA or EMA regulated records.

Yoshimi is a Computer System Validation and Compliance Manager and subject matter expert with over 17 years of experience. Prior to becoming a Computer System Validation and Compliance Manager, Yoshimi was a scientist for 10 years becoming a Senior Molecular Biologist and Senior Serologist. Both fields go hand in hand as Yoshimi is currently working at a company that builds software that the CDC uses to track disease outbreaks, and also software that track some of the clinical trials for COVID 19.

Yoshimi holds a B.A. in Biology and Psychology from University of Maryland at Baltimore County.