08 Oct 2012, BioSpectrum Bureau , BioSpectrum
Bangalore: Goose, a provider of pharmaceutical business re-engineering solutions, has launched Goose Proofreader, a 21 CFR part 11 compliant solution that enables excellent review of printed materials. Two pharmaceutical companies in India, Glenmark Pharmaceuticals and Aurobindo Pharma, have begun to use the solution, said the company.
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.
Mr Deb Pattnaik, founder & CEO of Goose, said, "Our goal is to make Goose Proofreader as an industry standard. It's 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."
According to FDA enforcement report in 2012 (Medmarc- Foley & Lardner LLP), total product recalls for the year 2004-11 have increased from 4,670 to 9,288, which includes class I, II & III recalls. Industry experts say that 35 percent to 40 percent of pharma product recalls happen due to faulty packaging and mislabeling. From the years 2004-12, there were 15 percent class one drug recalls for mislabeling. Therefore, it is critical for companies to provide accurate printed material. This would mean that the printing components of the packaging workflow should work efficiently.
Goose Proofreader compares and proofreads artwork files and leaflets and gives detailed report on the derived results.