Sanofi selected Compliance Gurus out of 7 vendors to assess our current Data Integrity Program to ensure it was compliant with federal and international rules and guidances. They not only quickly identified all of our compliance gaps, they also presented all of the compliance gaps and recommendations to our senior management team. Subsequently, they successfully overhauled our entire Data Integrity Program by creating several CSV templates, SOPs, Work Instructions, and a 21 CFR Part 11 assessment. As a result, we have become a trusted partner with Compliance Gurus.

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.

We hired Compliance Gurus to help us select a software vendor to choose for our Global Supply Chain solution. They helped Novartis vet four software vendors through their 21 CFR Part 11 compliant software vendor audit checklist. Subsequently, we chose the Oracle Fusion ERP solution that best fit the needs of our user population as well as our need to comply with FDA’s 21 CFR Part 11 federal rule. In addition, Compliance Gurus assisted us with the validation and implementation of the Oracle Fusion solution. The end result was a global ERP solution that streamlined our entire Supply Chain process while ensuring we validated the software application for its intended use and therefore, was compliant with 21 CFR Part 11.