For the multibillion-dollar pharmaceutical manufacturing industry, compliance with everchanging government regulations is a way of life. It is also an everyday reality that mandates drug companies to stay on top of all the latest technology to not only meet the vast and growing array of specs and protocols, but also continue to deliver better products and services to their customers and end-user patients.
Pulling off such a feat on a daily basis in a cost-effective way requires superior QC (quality control) competence at all levels of the manufacturing and distribution processes—not the least of which comes with producing packaging, labeling and marketing materials.
“In 2007, there were significant process changes implemented for product labeling and marketing materials,” relates Janssen-Ortho Inc. product packaging manager Louise Swinton, for the rendering of Pharmaceutical Advertising Advisory Board (PAAB)-approved text, as well and regulatory-issued product monographs and labeling copy approved by Health Canada.
The new changes had significant repercussions for the Toronto-headquartered pharmaceutical innovator that markets and distributes a broad range of medications used in the treatments of psychiatric and neurological disorders—including dementia and attention deficit hyperactivity disorder—as well as various treatments for cancer, gastroenterology, infectious disease and urology, among others.
Requiring strict regulatory compliance for documentation for these prescription products, the company was prompted to look for a technology-based alternative to the age-old human proofreading practices, which were often just too tedious and time-consuming, Swinton recalls, in addition to not always being infallible.
After looking around for commercially available solutions, the company settled on the Docu-Proof software developed by Global Vision Inc., a Montreal-based software designer specializing in proofreading solutions to provide optimal content integrity for companies like Janssen-Ortho through elimination of text and artwork errors during the creation workflow.
Essentially serving as an automated text inspector, the Docu-Proof solution was put through a rigorous pilot testing program at Janssen-Ortho, according to Swinton, passing it with flying colors.
“What was especially eye-catching were the results after conducting a few head-to-head, human versus electronic proofing tests—with Docu-Proof far and away the clear winner,” Swinton told Canadian Packaging in a recent interview.
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