Validation--how much can the world afford? Are we getting value for money?

The author raises questions not usually considered in discussions of validation: "How much validation can the world afford?," "Are we getting value for money?," and "What's in it for the patient?." The paper develops the theme that, while validation is undoubtedly important, the pharmaceutical industry has not given adequate thought as to whether the benefits of validation outweigh the costs in implementation of validation.