A guide for the deployment, validation, and accreditation of clinical digital pathology tools

Digital pathology (DP) has become an integral part of modern diagnostic practice, enabling efficient workflows, reproducible assessments, and the integration of computational tools. Whereas many institutions are transitioning toward digital diagnostics, deployment, validation, and routine usage of DP tools in clinical settings remains a major challenge. Existing recommendations often remain high-level, leaving laboratories without detailed, practical guidance on how to structure and document validation processes in real-world settings. To address this gap, we present a framework derived from the experience of Geneva University Hospitals (HUG), which since 2019 has operated a fully digital primary diagnostic workflow processing more than 230,000 slides annually. Drawing on this implementation, we outline best practices and lessons learned for the development, deployment, validation, and accreditation of DP tools. Document templates are also provided, which may serve as adaptable blueprints for other laboratories. This practical guide is intended to support reproducible, transparent, and audit-ready validation processes, helping institutions bridge the gap between general recommendations and operational deployment of DP tools in accredited diagnostic environments.