When Bill DiFabio found himself eating fish and chips at 11:30 p.m. at his equipment vendor's plant in England 3 miles from home he was not entirely unpleased. As the associate manager packaging for West Orange NJ-based pharmaceuticals maker Organon Inc. he had traveled to England in late '95 to check out and accept a new in-line vial labeler. The supplier Newman Machinery (Belle Mead NJ) manufactures the labeler at its U.K. plant and world headquarters. Needing additional production capacity for a new product-a liquid parenteral product used in surgery-Organon purchased the labeler for a spring '96 installation to label 5- and 10-mL glass vials of the drug. The machine installed in Organon's Allentown PA plant is equipped with an Itran machine-vision system from Acuity Imaging (Nashua NH) that inspects lot and expiration date codes. So what was DiFabio doing on Newman's plant floor at 11:30 p.m.? In a word validation. "Many times you go check out a machine and the vendor runs it 20 minutes performs a changeover runs it 20 more and you're done" explains DiFabio. "And then when you get home your validation people have to sit with you and pore through the manuals to come up with a validation protocol. And you're not even sure you can execute the protocol because you're not that familiar with the machine!"