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

Software Quality Professional, September, 2004 by Neill, Colin J; Theisen, Timothy W

This article investigates the software-supplier auditing practices in the pharmaceutical manufacturing environment by reviewing 17 quality audit reports performed between 1992 and 2003 by a major international pharmaceutical company. From this analysis three novel time frames of audit maturity (eras) are defined on the basis of government regulation enforcement patterns, supplier quality practices, and the pharmaceutical customer's evolving expectations of quality and auditing practices. Increased government scrutiny resulted in the pharmaceutical company making increasingly greater demands on its suppliers to establish and comply with quality management practices as a contractual obligation. The new maturity eras are described and proposed as a new dimension for audit maturity in...

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