Cliff Campbell is senior consultant at KPC.
Quality Quartets in Risk-Based Qualification:
Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.
Quality Quartets in Risk-Based Qualification: ICH Q9(R1) Considerations
Quality Quartets in Risk-Based Qualification
Quality Quartet Registers connect Quality Quartets to their process system or unit operation “parent.”
Points to Consider for Knowledge Management Acceleration
Quality quartets support an integrated and stable combination of commissioning and qualification and quality risk management processes.