Compliance Gurus and its team of seasoned experts came in and guided Takeda through a CSA implementation plan to be compliant with the FDA’s CSA principles and guidances. Their risk-based approach based on Patient Safety, Product Quality, and Data Integrity not only helped our company to be compliant with FDA’s CSA principles as well as industry standards, but also significantly reduced our time and costs associated with each validation and implementation for our GxP software applications.
