|
|
| Project Name: | Proofreading Solution |
| Project Sponsor: | Complete Inspection Systems |
| Time of Performance: | January - December 2003 |
| Program Manager: | Arlene Gerst |
Contex Scanner Used for Proofreading Solution
As the USFDA tightens controls over the accuracy of labeling content, drug makers
continue to respond with more thorough checking of all packaging components. But,
when consumers and the court system demand 100% accountability for even the most
minute errors, guaranteeing absolute label accuracy becomes essential. Something as
"minor" as a missed hyphen can turn a "1-2 tablet dosage" into a "12 tablet dosage",
a potentially deadly oversight.
Many companies have started using automated proofreading systems to relieve quality
analysts from the tedium of reading older labels and cartons each time new text is
introduced. But, despite the improvements and 200% inspection policies, labeling
mistakes and omissions remain the largest reason for recalls in the pharmaceutical
industry.
Automated proofreading systems have been well suited for checking electronic documents
during copy creation but, during the rest of the document creation process, much of the
activity is outside the company's control. Documents are sent off to publishers who
export these documents to different application. They are manipulated and reformatted
to create printed proofs. Regulators make their changes which are then incorporated back
into the original documents and re-checked. When everything is approved, the documents
are sent off to
print labels, cartons, or inserts by the tens of thousands.
A missing hyphen caused by the occasional fleck of dirt passing through a printer is not
likely to be caught by even the best quality assurance team. Unfortunately, most of this
process falls outside the scope of automated proofreading systems. Quality Assurance still
has to rely heavily on manual visual inspection.
To address this problem, Complete Inspection Systems has created a new proofreading system,
designed from the ground up to cover the full range of visual inspection tasks. Their
flagship product, AutoProof Pro, is designed to keep an eye out for any labeling problems
from first draft right through the final production process. AutoProof Pro is a suite of
tightly integrated tools which work together to assure the accuracy of day-to-day Quality
Assurance tasks. The software is designed to run on standard office computers and peripherals
so the responsibilities of the system can be shared between publishing, printing, and production
services. AutoProof Pro validates documents even if they have been reformatted, exported to
other applications, or even authored on different operating systems. To inspect printed materials,
AutoProof Pro uses very advanced visual comparison techniques, which are tuned to pick up even
the smallest errors.
Printed materials are scanned using the Contex Cougar or other Contex models up to 50-inches
in width for sheet material. AutoProof Pro compares sample documents to the original approved
master, looking for any changes whether they are in the written copy, document formatting,
graphics, bar coding, or even imperfections created by mechanical printing problems. For complete
end-to-end product validation, AutoProof Pro is often used to compare packing components removed
directly from the production line to validate them against the original master.
Pharmaceutical companies using AutoProof Pro have embraced the system with great enthusiasm.
"Automating text comparison and related functions guarantees that we consistently find 100% of
the errors. Jobs which tied up two analysts for 6-8 hours are now handled by a single person
in minutes."
For more information, visit:
http://www.completeinspectionsystems.com.
|
