Bob acted on many occasions as an expert in the Computer Validation field. He offered the “voice of the general industry” while providing the “insight of current regulatory thinking” of the agency in a quest for a paperless GMP system. He provided this guidance during our site evaluation of electronic records while acting as a conduit to consulting experts in the field as well. This “well networked” experience proved invaluable in our assessment by saving us thousands of dollars in consulting fees which we would have incurred without his help.
Also, Bob lead the corporation in harmonizing the various sites in the use of Trackwise software from Sparta Systems. Bob championed the features and benefits and provided our site with the much needed means to electronically track, recall and review all actions needed in responses to customer and internal audit needs, as well as systems improvements and enhancements. At the time of Bob’s leaving Fisher, he had already begun development on phase II of the system to include documentation management.
Bob’s last major contribution for our site included an exhaustive internal audit of our systems. As a Quality Systems expert, Bob was able to provide valuable insight into GMP issues that we had not considered. In effecting the corrective actions, the observations provided by Bob have made us a more competitive and effective business unit.
I highly recommend Bob in these capacities.
Jeffrey D. Coffin
Clintrak Clinical Labeling Services