A Cross-Functional Team Approach to Implementing and Managing Laboratory Automation in the Quality Control Laboratory

摘要

Poorly defined project goals and an inadequate infrastructure have hindered previous attempts to initiate automation projects in the Novartis Quality Control laboratory. This haphazard approach has been replaced with well-defined project expectations and agreement among the functional groups that make up the project infrastructure to aggressively support the automation project goals. This presentation was given at the 2001 International Symposium for Laboratory Automation and Robotics (ISLAR) held in Boston, MA, October 14–17, 2001, and is reproduced here with the permission of ISLAR. The full manuscript is available on CD-Rom and can be acquired by contacting Christine O'Neil, 508-497-2224; email: islar{at}islar.com or access the ISLAR website at www.islar.com Previous SectionNext Section BACKGROUND Shortly after the formation of the Novartis Pharmaceutical Corporation in April 1997 the US Quality Control Department formed a small (two-person) laboratory automation group. The team was directed to automate content uniformity and dissolution testing associated with the new company's drug product portfolio. The group was responsible for all aspects of the program, including: