Developing an effective toxicology/quality assurance partnership. Improving quality, compliance, and cooperation.

Toxicology and Quality Assurance (QA) at Eli Lilly and Company are well integrated, yet still independent organizations that are aligned with the same overall business objective: to efficiently deliver a high-quality product to the customer. One of the keys to success has been the implementation of a monitoring/metric and trend analysis program of key work processes that are central to the delivery of final product. Our metrics program indicates that the multiple changes that we have made have resulted in a higher quality product. This paper will discuss the practical changes we have made as a part of our Total Quality journey. This article is based solely on the authors' experiences while at Eli Lilly and Company.