In-Line vs. Off-Line Verification Systems • FDA does not mandate how labels should be inspected • Off-line inspection is an economical and easy way to begin an label verification program • Combination of off-line and in-line inspection is possible and the recommended approach In-Line Verification Off-Line Verification 100% label inspection, automated process Used for random sampling, manual process Requires direct integration with label printing equipment Sampling interval defined by the labeler, but typically at beginning and end of label production run Not possible for direct part marking Off-line verifiers can inspect both labels and direct part marks