Efficiently managing quality and compliance on a global scale across multiple markets and languages is crucial in the highly regulated pharmaceutical environment. It affects patient well-being, access to medicine, product success and business sustainability. The globally known Novo Nordisk, headquartered in Bagsværd, Denmark, takes an uncompromising approach to quality and business ethics set out in “The Novo Nordisk Way”, a philosophy built on guiding principles developed by a company whose products are marketed in over 170 countries. Ensuring quality and compliance in labeling and packaging is, unsurprisingly, imperative.
As a result of strong growth and expansion in markets, proofreaders at Novo Nordisk faced a higher volume of material and recognized that existing manual processes needed to be improved. It was the early 2000s, and all proofreading was performed manually by dedicated proofreaders in all major European languages, many non-European languages, and in languages with non-Latin alphabets such as Arabic, Chinese, Greek, Russian and Thai.
Each time a product changed, labeling and packaging also had to be changed and proofread manually for possible errors. On top of that, artwork for new products also had to be proofread. The process was long and somewhat convoluted. The individual responsible for the product manuscript would receive a translation from the international affiliate in the local language. At the same time, the manuscript went to artwork. Once the artwork had been completed, it was printed out and compared to the original manuscript. Whenever an error was found, the artwork had to be returned to the graphics division for correction. Once completed, the artwork was printed again and the proofreading process repeated. This entire process was done manually. It was time-consuming and involved unnecessary cost and risk of error.
As experts in their field, the proofreaders understood the risks of manual proofreading. Novo Nordisk began investigating possible solutions. The solution had to be reliable, and Novo Nordisk wanted a partner it could work together with closely over the long term. A key criterion: the solution had to be future-proof (able to adapt to any upcoming major changes). In addition, the solution had to offer greater efficiency at lower cost for the increasing volume of work.
Choosing TVT®, the Text Verification Tool®
Novo Nordisk brought its list of requirements to Schlafender Hase. After the two companies worked closely together to ensure that these requirements could be met, Novo Nordisk implemented TVT in 2005.
The benefits were immediate. As Torben Hangler, Translation Coordinator for Novo Nordisk, explains: “In the very early days of implementation, manual proofreading had already been performed for one product and the artwork subsequently sent to print. When we ran the artwork through TVT software, however, we discovered a serious deviation. We quickly realized the value of working with verification software.”
He cites another example related to updating labels and packaging: “The tablet colour of one product had been changed from blue to green. The image was green, but we picked up a legacy reference in the text to the word ‘blue’. This error had been overlooked.” Hangler, who is also a graphic designer by training and profession and understands the needs of graphics departments, concludes: “TVT has been incredibly valuable for verifying our artwork.”
Novo Nordisk has been working with TVT for over 15 years. The software has also been indispensable for large-scale projects involving template changes. When Novo Nordisk transitioned over 1,400 package and leaflet template files from Core format to Adobe InDesign, Schlafender Hase and Novo Nordisk partnered closely to ensure the project went smoothly. “The time savings for renderings were substantial,” Hangler says, “and the project was completed on time, compliantly and without error. These results would not have been possible without TVT.”
“The return on investment was achieved within a few months,” says Peter Egvang, Senior Regulatory Intelligence Manager of Regulatory Affairs at Novo Nordisk, “since TVT not only dramatically reduced the high amount of manual proofreading work, but also accelerated and simplified the approval process of our packaging material.”
Furthermore, the volume of work that can now be performed at Novo Nordisk has increased significantly, while decreasing the stress involved in manual proofreading tasks.
The expertise and knowledge gained by Novo Nordisk and Schlafender Hase from their long-term relationship has resulted in custom features that are now standard in TVT and benefit all customers.
Torben Hangler has been working together with Schlafender Hase from the earliest days of implementation. “Our working relationship has been excellent,” says Hangler. “Schlafender Hase listens and understand our needs, building the results of our work together into future versions. A true partnership has developed over the years, with knowledge and experience flowing both ways – we’re often asked our views on possible new features during the development of future versions.”
Frank Hessler, Managing Director of Schlafender Hase, explains: “Our ongoing business relationship with Novo Nordisk over the past 15 years has been hugely beneficial to everyone. We’ve gained a lot of insights that have helped make TVT easier to use and even more efficient. Ultimately, the new features growing out of our partnership have been implemented worldwide, so that all customers benefit from improved quality processes in proofreading.”
About Novo Nordisk
Headquartered in Bagsværd, Denmark, Novo Nordisk is a global healthcare company employing over 40,000 people in 80 countries. It is a world leader in diabetes care, with a portfolio including obesity care, haemophilia care, growth hormone therapy, and hormone replacement therapy. Novo Nordisk’s products are marketed in over 170 countries, and its diabetes care products are used by over 27 million people worldwide. The company invests approximately 13% of its sales revenue in its research and development division, which employs over 5,000 people. Find out more on www.novonordisk.com