Over the past 24 months, the leadership of the Bio-Process Systems Alliance (BPSA) has initiated a pilot program to demonstrate the joint feasibility of collecting and sharing pertinent industry business data. We began with “quality-complaint data” centered on the premise that product complaints are tightly associated with product-quality defects in single-use systems (SUSs). This approach can be viewed as “risk assessment 101.” BPSA’s Representation of the Single-Use Industry BPSA is an industry organization primarily comprising drug manufacturers, single-use system suppliers,…