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Digital System Validation Process

Meaning

The Digital System Validation Process is the formalized, documented procedure used to confirm that a software system, especially one handling patient hormonal data or supporting clinical decision-making, meets its specified requirements and consistently functions as intended. This rigorous process is a prerequisite for deploying any new technology in a clinical environment to ensure data accuracy, reliability, and security across all functions. Validation confirms the system’s fitness for its intended clinical use, minimizing the risk of technological error in critical patient care.