The New Imperative: IT Supplier Quality Assurance Under ICH E6(R3)
As the July 2025 implementation date for ICH E6(R3) approaches, a significant evolution in regulatory expectations is becoming clear. Discussions at the recent ACT Workshop confirmed what many quality professionals have anticipated: regulatory authorities are intensifying their focus on IT service provider oversight, and eliminating the current gap of not conducting direct routine inspections of IT […]