The Identity Utility: Architecting Global IAM as Foundational GxP Infrastructure

In regulated industries operating under Good Practice (GxP) requirements — pharmaceuticals, medical devices, clinical research — identity and access management is not merely a security control but foundational infrastructure that directly impacts product quality, patient safety, and regulatory compliance. This paper introduces the 'Identity Utility' concept: architecting IAM as a shared, reliable, always-available service comparable to electrical power or telecommunications infrastructure. The framework addresses the unique requirements of GxP environments where identity controls must satisfy FDA 21 CFR Part 11, EU Annex 11, and ICH guidelines while operating at global scale across manufacturing sites, research facilities, clinical trial locations, and supply chain partners.

The architecture covers electronic signature governance, audit trail integrity, role-based access for quality management systems, and cross-border identity federation for multinational operations.