Much of NSF Pharma Biotech Consulting’s work involves helping companies remediate flawed quality systems. This is usually done as a result of threatened or actual enforcement action by regulatory agencies. In these circumstances, companies are desperate and willing to do ‘whatever it takes’ without a full understanding of what that means. While expansive in concept, ‘whatever it takes,’ for many, means simply deploying internal and external resources to design and document a new quality management system. This is a significant commitment by management in resources, but unless the cause (how did this happen?) is also considered, the effort is doomed to fail.