Using Risk Ranking & Filtering in Computer System Validation (CSV): A Practical Guide

Using Risk Ranking & Filtering in Computer System Validation (CSV): A Practical Guide Using Risk Ranking and Filtering in Computer System Validation (CSV) As pharmaceutical companies embrace digital transformation, the number of computerized systems subject to validation has multiplied. Validating all systems equally is inefficient and no longer aligned with current regulatory thinking. Instead, regulators now expect a risk-based approach to Computer System Validation (CSV), leveraging tools like Risk Ranking and Filtering (RRF) to determine the appropriate validation depth. This guide provides a practical, step-by-step framework to implement RRF in CSV. From classification criteria and scoring models to lifecycle integration…

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