ABSTRACT
If you were the chief executive officer of a successful pharmaceutical company would you want to know that your company was meeting and exceeding customer expectations? Do you know who your customers are? Your customers may be consumers of the product, patients and doctors, purchasers (managed care), shareholders, or regulatory authorities. In fact, your customers are all of these. Although their expectations will vary, the company has the common goal of fulfilling all their expectations. There are different ways to determine customer expectations, but without an adequate evaluations tool, a standardized comparison to a common reference point cannot be made. Current regulations for medical devices (21 CFR 820) and good laboratory practices (21 CFR 58 and 40 CFR 160) include requirements for formalized and well-established and, maintained internal auditing programs. Current expectations of most other FDA-regulated industries, such as biotechnology and pharmaceuticals, are no different, although the regulations do not specifically mandate the installation of an internal auditing program. It is only a matter of time before these requirements are more clearly defined and codified in these and other areas.
