Proof Reading 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 www.completeinspectionsystems.com.
