Traceability Matrix in Validation: Linking URS, Risk Assessment, Protocols & Final Reports Creating a Traceability Matrix in Pharma Validation: Connecting URS, Risk Assessments, Protocols, and Reports The traceability matrix is a critical document in pharmaceutical validation that ensures every user requirement (URS) is tested, verified, and documented. It bridges the gap between specifications, risk analysis, protocol design, and final validation outcomes, establishing a clear path of accountability and compliance across the validation lifecycle. From GMP equipment qualification to computer system validation (CSV), regulators expect traceability to be clearly documented, particularly in complex, risk-based validation models. This article provides a step-by-step…