Case Study: Recordati achieves no inspection findings with Veeva CTMS

Recordati passes inspection with no findings using Veeva CTMS

Recordati, a global pharmaceutical company, faced significant compliance and oversight challenges under new ICH GCP E6(R3) guidelines, particularly while managing fully outsourced clinical trials. To improve data quality, monitoring, and regulatory compliance, they partnered with vendor Veeva Systems to implement a hybrid operating model using the Veeva Clinical Operations platform, including Veeva CTMS and Veeva eTMF.

By implementing Veeva's centralized systems, Recordati brought key oversight processes in-house. The solution enabled them to standardize and automate processes, eliminating over 20 manual trackers and achieving a 25% faster document ingestion cycle. Most notably, Veeva's platform helped Recordati pass a recent inspection with zero findings, providing immediate evidence of their robust oversight and significantly enhancing inspection readiness.

Recordati