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.
