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HBOK 1-022

Title FDA Regulations and Auditing Practices for Software Suppliers at a Pharmaceutical Manufacturer
Author(s) Timothy W. Theisen and Colin J. Neill
Source Software Quality Professional
Topic Strategic Planning Process

Strategic Management

Qualities of Customer-Focused Organizations

Abstract A review of 17 quality audit reports performed by an international pharmaceutical company between 1992 and 2003 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.
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Reference Code 1-022


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