Goose 'Proofreader' to review printed materials; to mitigate product recall risks of pharma cos
The Hyderabad-based Goose, a specialist in providing pharmaceutical business re-engineering solutions, has come out with a Proofreader, a 21 CFR part 11 compliant solution that enables excellent review of printed materials.
The advanced product brings major benefits to the global pharma organizations. Two leading pharma companies Glenmark and Aurobindo have begun to use the Goose Proofreader. It reduces errors in the printed materials, helps to mitigate the risk of product recalls and thereby potentially saves millions.
For several years, pharma companies have been manually proofreading the leaflets, artwork and other printed materials. Relying on manual proofreading always increases the chances of error. These errors could be minor but the losses incurred would result in millions of dollars followed by lawsuits. Every year pharma companies face losses due to product recalls. The electronic proofreading solution is economical in terms of reducing cost of printed materials and also streamlining the packaging process. It restructures the proofreading process, improves efficiency and reduces approval timings which in turn reduces product recall and increases product profitability.
The major challenge that the pharmaceutical industry faces today is to make the artwork error free. Goose Proofreader is engineered to deal with this challenge as it reduces the costly errors, increases accuracy and maximizes productivity.
“The objective is to make Goose Proofreader as an industry standard. It is a completely new alternative to manage document proofreading task. Usage in our client location has tackled even the most complex tasks like evaluation of multilingual texts, comparison of images in different angles at the same time adhering to strict FDA regulations effortlessly. This is a key solution to current processes which is human error prone leading to huge potential loss to the global pharmaceutical organizations,” said Deb Pattnaik, founder & CEO, Goose.
According to Medmarc- Foley & Lardner LLP which is an FDA enforcement report in 2012, total product recalls for the year 2004-2011 have increased from 4670 to 9288 which includes class I, II & III recalls. Industry experts say that 35 to 40 per cent of pharma product recalls happen due to faulty packaging and mislabelling. From the years 2004-2012, there were 15 per cent class one drug recalls for mislabelling. Therefore, it is critical for companies to provide accurate printed material. This would mean that the printing components of the packaging work-flow should work efficiently.
Goose Proofreader compares and proofreads artwork files and leaflets and gives detailed report on the derived results. The tool performs two types of comparisons. One is the Pixel to Pixel which helps compares images and texts. The second is the Text Verification which compares only texts.
Key features of Goose Proofreader solution is that it identifies differences in the texts and images. It also compares scanned copy with system generated copy. Other features include image rotation, auto crop, flip, resize, angle suggestion, overlay etc. for evaluating files. The solution generates detailed report for pixel to pixel comparison and has the ability to read Barcode & Pharmacode.
The advanced capabilities of comparing sentence to sentence and word to word in documents are yet another feature of Goose Proofreader that the pharma industry can benefit from. It compares individual images present in the leaflet files and gives detailed report.