Case Study

Coloplast Achieves New Benchmarks for Compliance, Efficiency and Consistency

Coloplast A/S is a Danish multinational company that develops, manufactures and markets medical devices and services related to ostomy, urology, continence, and wound care. Kallik’s Veraciti solution has achieved benefits for Coloplast in terms of speed of adoption and productivity gains and so enabling the business to minimize time to market for new product launches.

Challenges:

We originally thought the issues we were trying to solve were limited to labeling, but we quickly realized that we had invested in a solution that enabled us to satisfy even the most stringent regulatory requirements.

Jette Byg, Head of Global Labeling, GQA, Coloplast

Our IT President stated that this was the first time he had not encountered any resistance to the introduction of a new system. Instead, users were asking for Veraciti implementation to be given priority over other projects.

Jette Byg, Head of Global Labeling, GQA, Coloplast

In terms of its label and artwork management, prior to Kallik having a non-task driven PDF workflow underpinned by approvals sent via email was making it almost impossible to prove compliance. The entire process was time-consuming and making it difficult to track audit changes due to the large volume of artwork amends being processed. Coloplast also needed to react quickly and effectively to new legislation and regulation requirements. UDI was fast approaching and stakeholders knew their current processes would not fulfil business requirements and could potentially delay meeting key compliance targets.

“We simply didn’t have the time or resources to meet required levels of quality without causing major delays,” confirms Jette Byg, Head of Global Labeling, GQA, Coloplast, who is responsible for the end-to-end artwork process.

“This resulted in us being constantly behind and not able to prove compliance in acceptable time frames,” she adds. “Ultimately, this led to delayed product launches.”

As a result, Byg and her team started to look for a single solution capable of managing all the company’s global labeling processes, from data collation to final print at the factory. A core requirement was that all content had to be manageable from within a single platform, including content shared with external production and print partners.

“We looked at many options, but Kallik’s Veraciti was the only product that could offer this,” she states.      

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How Kallik Helped:

Having satisfied themselves that Veraciti was the best fit, Kallik worked closely with Byg and her team to help rationalize label templates and artwork content to minimize the number of unique assets needing to be managed.

This led to greater levels of standardization, while reducing the risk of duplication, she notes, adding that Kallik’s unique Automated Artwork Generator has also been invaluable to the artwork production, enabling Coloplast to keep labels compliant within evolving markets.

Results:

Having all the artwork data in Veraciti has also allowed Coloplast to automate the creation of a large proportion of artwork labels with one simple process. In practical terms, what once took a conventional artwork studio days/weeks to produce, now takes minutes — if not seconds.

“The results were obvious and very clear to us,” says Byg. “We can now achieve global artwork consistency across all our brands, from multiple packaging formats and complex Information for Use leaflets.”

Identifying and updating all labels impacted by regulatory and/or local market changes is also now much less of a challenge, she adds, as all impacted labels can be quickly identified, changed and automatically regenerated for approval using Veraciti’s unique ‘Where Used’ function. “UDI compliance has also been made easier by simplifying the capture of labeling content required for submission to the Global UDI Database (GUDID),” she points out.

Due to the flexibility of Kallik’s cloud-based platform and its ease of use, Coloplast has also been able to engage external business units to assist on large scale projects. Veraciti has also simplified entry into new markets such as South America, where countries such as Columbia require market specific labeling and packaging, says this delighted customer.

VeracitiTM Global Source of Labeling Truth

Business benefits at a glance:

Compliance in real-time

Full compliance adherence can now be proven in seconds as opposed to weeks or months

 

 

compliance in seconds

Global Efficiency

Data can be safely and securely shared globally, internally and with Third Party Designer Studios, Printers and Manufacturers

 

 

global efficiency

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