Ambu A/S, a leading Danish company specializing in single-use endoscopy solutions and diagnostic and life-supporting equipment, solved significant challenges with their existing labeling system by implementing Kallik’s end-to-end cloud-based software, Veraciti™. With Veraciti, Ambu managed to achieve complete compliance, accuracy and greatly increased the efficiency of their labeling and artwork management process to ultimately increase speed-to-market.
 

The Challenges

Ambu's rapid expansion and innovative product development rendered their existing labeling inadequate for their evolving needs. With the introduction of numerous new products and updates to existing ones, the limitations of their outdated system became increasingly problematic.

Ambu's Labeling Manager emphasized the overwhelming task of managing, tracking and remembering everything when handling the process. “I was the only one actually creating labels in Ambu at that time. Now we have a lot of people creating labels within Veraciti™ and if we should remember all these things going forward then I think it will be very messy. So Kallik, or rather the Veraciti™ system, actually handles most of these things for us now."The absence of an efficient, all-encompassing system hindered compliance maintenance and label management across their extensive product portfolio - an issue which Veraciti™ solved.
 

The Solution

To address these challenges, Ambu implemented Kallik's Veraciti™ system. After considering several other systems, they chose Veraciti™ for its robust features and flexibility. Unlike traditional label management systems, Veraciti™ offered an end-to-end labeling solution that included handling phrases and symbols, making it easy to search for and reuse components across different products. 

Ambu’s Labeling Manager highlighted the system's abilities, “You can actually search for phrases, you can search for symbols and then you can use it across a lot of different products. Also when we have updates - it could be a phrase, it could be a symbol - then you will actually be warned when you create a project brief, the brief will tell you that you’ve not used the latest version of the symbol/phrase and to do something to update it.”

The implementation of Veraciti™ was a collaborative effort between Kallik and Ambu. Ambu’s ERP Consultant praised the data migration process, noting that Kallik's team was hands-on and provided exceptional support, including multiple visits to Denmark to ensure a smooth transition. This partnership was instrumental in successfully migrating data and training Ambu's team to utilize the new system effectively.

The ERP team commented on the process, “We had a very good migration of data because we had a team from Kallik and a team from Ambu working together and the team from Kallik was also in Denmark several times. I think the support from Kallik was brilliant.”
 

The adoption of Kallik's Veraciti™ system brought numerous benefits to Ambu:

1. Enhanced Efficiency and Speed: With Veraciti™, Ambu can now make changes faster, significantly reducing time-to-market for their products. The system's ability to manage and reuse phrases and symbols streamlined the labeling process, which was previously time-consuming and error-prone.

2. Improved Compliance: Veraciti's comprehensive audit log and tracking capabilities ensured that Ambu was in full compliance with regulatory requirements. Ambu’s Labeling Manager noted that during audits and visits from authorized authorities, Ambu could easily share all necessary information, demonstrating control over their labeling processes. “We are in full compliance. When we have audits and our authorized authority visiting us we can share all information that is needed and because everything is logged we have an audit log to show them everything every time we make a change.”

3. Centralised Label Management: The Veraciti™ system allowed Ambu to control all their labels within one unified platform. This centralization made it easier to manage updates and maintain consistency across their product range. Ambu’s Labeling Manager expressed her relief and satisfaction, stating, "We are now in control of all our labels in one system."

4. Scalability and Future-Proofing: As Ambu continues to grow and innovate, Veraciti™ provides a scalable solution that can adapt to their evolving needs. The system's flexibility to add extra features as required ensures that Ambu can continue to meet market demands and regulatory changes efficiently.

In the medical device industries, accurate and effective labeling is crucial to ensure patient safety and regulatory compliance. Labels provide essential information about product usage, storage handling, size indication, and other critical warnings. Mislabeling or inadequate labeling can lead to serious health risks, including incorrect usage of devices, which can
result in severe patient harm.

Given the high stakes, it is imperative for companies to adopt a system that ensures accuracy and consistency in labeling from the outset. Kallik's Veraciti™ system exemplifies this by providing a comprehensive, end-to-end labeling solution that ensures full regulatory compliance. By automating and streamlining the labeling process, Veraciti™ minimizes the risk of human error, ensures up-to-date information, and supports efficient management of label changes.

In conclusion, the partnership between Ambu and Kallik has been transformative for Ambu's labeling processes. Are you interested in learning more about how Kallik can help your business to streamline and simplify your labeling and artwork management? Speak to one of our experts today. Call +44 (0) 1827 318100, email enquiries@kallik.com, or request a demo here.