What is OneGxP?
OneGxP is a unified quality and compliance framework that brings together all GxP domains under one harmonized way of working. Instead of separate interpretations of GLP, GCP and GMP across teams, sites and systems, OneGxP establishes a single operating model: one governance structure, one validation philosophy, one data integrity lens.
Core Principles of OneGxP
- Harmonization – common procedures, templates and workflows across GLP, GCP and GMP.
- Standardization – shared naming, lifecycle states and documentation structures.
- Integration – quality systems that connect instead of operate as islands.
- Enterprise Architecture – one approach to validation, data integrity and governance for LIMS, ELN, MES, CDS and beyond.
- Risk-based Compliance – focus on product quality, patient safety and data reliability.
Why OneGxP matters
Without OneGxP, organizations live with duplicated systems, inconsistent SOPs and multiple “versions” of GxP. With OneGxP, the enterprise moves to a single quality language – easier audits, cleaner data, simpler digital transformation and a stronger compliance posture across labs, clinical and manufacturing.