Whether applied to business security, product specification, financial exposure or personnel safety, quality is a key element underpinning any biopharmaceutical risk mitigation strategy. A quality system should not be inherently dependent upon personnel, nor should it rely solely on people to ensure the quality of the products manufactured. Irrespective of human resources, the system itself should provide consistency, addressing risk from design inception through to product delivery, ensuring that robust processes are in place that minimize risk to the product…