In response to lee
lee,
I never recieved any responses to this post, but what I ended up doing is determining that the system is required to print various label sizes with barcoding, text, and graphics - though not all labels required each content area. The basis of my validation was to only prove the printer can reproducibly print "good" labels. Some assumptions must be made and documented in the protocol - 1. that the software was developed under good software practices by the vendor (Zebra) 2. Our facility has every label 100% inspected for appearance, lot, date and verifies the correct barcoding at X-number of labels.
From here I wrote the validation to only prove the ability of the system to print "good" labels. To prove this I created two verifications:
1. Tested the ability of the printer to print each content area separately on the largest label and the smallest label (inbetween understood to be acceptable). Example: Barcoding was printed 3 times on the largest labels and 3 times on the smallest labels and verified using a barcodes scanner. But for text, I made sure that they filled in the lot and date areas using at least 3 of each alpha and numberic character (a-z, 0-9). To ensure the character formation/readability. The graphics received a visual inspection against the part drawing.
2. I had one of every label printed and visually verified for layout to ensure that there would be no problems with any label formats.
If you need any further clarification post email and I will contact you.
Good Luck,
Grasshopper
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08-30-06 06:11 AM - 
11-20-06 04:01 AM -