Learn about Zimmer Biomet’s implementation of their Global Enterprise Labeling System and its use in preparing for EU MDR
New labeling system enables regulatory compliance and unprecendented systems efficiencies at medical device manufacturer Zimmer Biomet
As medical device manufacturer Zimmer Biomet grew through merger and acquisition, they sought to harmonize different labeling systems across their global facilities with two goals in mind: to gain the efficiencies that standardized labeling processes offer; and to enable global compliance, especially with the pending European Medical Device Regulation (EU MDR). Zimmer Biomet chose ROBAR software from Innovatum, with label design and print powered by BarTender®.
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~ROBAR Online Provides Unparalleled, Scalable Security and Accessibility Capabilities~
Innovatum, Inc. has announced the availability of its highly vaunted ROBAR family of solutions for regulated labeling and UDI Compliance as a cloud based “hosted” service called “ROBAR online.” The expansion of services resets the bar for enterprise labeling capabilities and support in the life sciences industry.
The ROBAR family of products includes label design, management and printing, regulatory data management and submissions, and eIFU capabilities. Available as a single tenant solution, the ROBAR online solution includes all the capabilities and associated services that are expected from on-premise software. This includes expert consultation, implementation, integration, as well as validation assistance and on-going support.
Innovatum President and CEO Ardi Batmanghelidj said, “Through 15 years of acid testing by our customers, and as a result of our continuous improvement based on their feedback, the ROBAR on premise solution has become the leading enterprise labeling and UDI compliance software in the world. This expansion of services was made possible through diligent and dedicated efforts in managing the on premise solution for many of our customers. Along the way we embraced the growing need for cloud-based and online services, honing our skills for delivering a hosted solution regardless of its physical location. Our customer feedback has been key in providing this in-demand capability for Innovatum.”
He continued, “We are excited to bring this service to smaller companies without IT departments, and to industry leaders who feel comfortable having a world-class hosted solution.”
Innovatum is partnering with one of the world’s leading cloud based hosting companies to deliver
“ROBAR Online” in the most highly available and secure means possible. Integration with other systems such as ERP, MES and PLM remain as flexible and reliable as ever; customers always maintain access to their own data, which are not commingled with other data on the same server.
Headquartered in Atlanta, Georgia, Innovatum is a leading software and regulatory consulting company that specializes in life sciences labeling and UDI Compliance.
Labeling requirements are more complex than ever. These days, labeling within the life sciences industry needs to be data driven and dynamic to keep up with changing client needs and regulatory standards. Here’s a rundown on the top 5 trends in enterprise labeling.
Regulations – Changing regulations are having an impact across all industries, particularly those in which package labeling affects customer safety, such as pharmaceutical and medical device labeling. Regulatory standards include ePedigree, UDI, DQSA as well as many new International standards that are on the horizon.
Centralization—More and more companies are centralizing bar code labeling across multiple geographical locations. The three most important factors in centralization are: enabling labeling consistency, reducing IT maintenance costs and ensuring business continuity.
Customer responsiveness – Customers are demanding adherence to labeling requirements, which is leading to a supply chain that is directly intersecting with labeling. This development is largely in response to the clients’ own desire to maintain efficiency by having their providers stick to their individual labeling standards.
Integrated and data driven labeling – Although this concept is not a new one the growing demand for label accuracy is pushing the importance of data driven labeling. The data-driven approach enables the pulling in of dynamic data at label print time.
Supplier’s increasing role in labeling –Partners’ and suppliers’ expectations are reaching beyond meeting internal needs and becoming much more globally interconnected. The most important consideration in this regard are: cost of relabeling, reducing labeling errors and successful supply chain collaboration. Requirements for compliance with UDI make this more complex.
If you have any questions about these top five trends in Enterprise Labeling, contact our experts at Innovatum today.
These days, life sciences businesses dealing with global supply chains face an increasing number of important challenges. These include:
the need to increase supply chain transparency
the need to centralize label printing and have multiple remote printers at different geographic locations
using automation to reduce the number of label templates
changing labels rapidly to suit customer needs
providing labeling solutions in high volume
reducing the risk of counterfeit labels
reducing manufacturing costs
This last challenge is possibly one of the most important and an appropriate enterprise labeling is a great way to meet this challenge. An Enterprise Labeling Management System provides an enterprise class level of functionality and robustness, yet it can be scaled down to fit the smallest of organizations. Over time, you will begin to feel the pull of your growing supply chain, changing client demands and tightening government regulations. If you want to adapt to these changes with the most cost-effective solution, enterprise labeling is the way to go.
What is Enterprise Labeling?
Enterprise labeling for the life sciences industry centers around a database driven, and fully configurable computer system which tightly controls label design, rework, language translation, print and reprint and all of this can be done per 21 CFR Part 11 requirements. An enterprise labeling can save you money by reducing the waste of unnecessary stock by supporting on-demand printing as well as custom label design. The validated and automated nature of the system helps to eliminate labeling related errors that can result in expensive recalls.
Call our expert team at Innovatum today, and let’s discuss how we can help you reduce your enterprise labeling costs. We can configure a labeling solution that’s just right for your company’s needs. Let’s work together to take your enterprise labeling capabilities to the next level.
Browser-based printing solutions enable you to design and manage labels in a central location or locations and print from multiple geographic locations using only a browser. This approach delivers a number of advantages:
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