FDA Regulations and Auditing Practices for Software Suppliers at a Pharmaceutical Manufacturer

A review of 17 quality audit reports performed between 1992 and 2003 by an international pharmaceutical company identifies three time frames of audit maturity based on government regulation enforcement patterns, supplier quality practices, and the customer's changing expectations. Increased government surveillance caused the pharmaceutical company to make greater contractual demands on its suppliers to establish and comply with quality management practices. The maturity eras described are proposed as a new dimension for audit maturity in the pharmaceutical industry.