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Enhancing Compliance and Efficiency in Enterprise Labeling


Large enterprise companies face numerous challenges with their product labeling and artwork process. Compliance with regulations and getting products to market quickly can be a headache and requires a lot of manual effort. In addition, in regulated industries such as medical devices, pharma, and cosmetics, non compliance with labeling regulations could mean severe consequences. In addressing these challenges, enterprise labeling software is often overlooked. Below, we’ll look at what enterprise labeling software is, its benefits to enterprise companies, and why you should consider it.


What is Enterprise Labeling Software?


Enterprise labeling software is a specialized technology solution designed to automate and centralize the labeling process within an organization. It enables businesses to create, manage, and automate labeling across many departments, locations, and languages. It contains features such as end-to-end approval trails, automated change management and a dedicated asset search engine. This software empowers labeling and compliance professionals to ensure regulatory compliance while boosting efficiency and decreasing time to market.


How Enterprise Labeling Software Increases Compliance


  1. Meeting Regulatory Requirements: In regulated industries, compliance with labeling regulations is vital to ensure patient safety and product integrity. Enterprise labeling software provides a single platform to create and manage labels according to regulatory standards, such as FDA, EU MDR, and ISO. This software helps organizations stay updated with the latest regulatory changes and implement them seamlessly.

  2. Traceability and Audit Trail: Enterprise labeling software offers advanced tracking capabilities, ensuring complete traceability throughout the labeling process. Compliance professionals can easily track label versions, changes, and approvals, with access to an audit trail in case of regulatory audits. This level of traceability enhances transparency and accountability, reducing the risk of non- compliance.

  3. Automated Compliance Checks: Manual compliance checks are time-consuming and error-prone. Enterprise labeling software automates compliance checks across multiple artworks, verifying label content against regulatory requirements. It highlights any discrepancies or potential violations, allowing compliance professionals to rectify them before labels are printed or published. This automated validation saves time, minimizes errors, and mitigates compliance risks.


How Enterprise Labeling Software Boosts Efficiency


  1. Centralized Label Management: Enterprise labeling software centralizes label design, data management, and printing across the organization. It eliminates the need for multiple software applications and manual data transfers, reducing errors and increasing efficiency. By maintaining a centralized store of label templates and product data, you can easily access and update information.

  2. Streamlined Collaboration: With enterprise labeling software, different stakeholders involved in the labeling process can collaborate seamlessly. Compliance professionals, regulatory affairs teams, and marketing departments can work together in real-time. This reduces communication gaps and speeds up the label creation process. This collaborative approach ensures that labels comply with regulations while meeting branding and marketing requirements.

  3. Agile Labeling Changes: In highly regulated industries, labeling updates and changes are inevitable. Enterprise labeling software enables organizations to respond quickly to regulatory updates or product changes. With efficient workflows and approval processes, compliance professionals can implement labeling changes rapidly, ensuring compliance without causing delays in product launches.


A proven enterprise solution


Enterprise labeling software is now a key tool for many large enterprise companies, particularly in regulated industries. Companies like Teleflex, a medical devices manufacturer have used it to great effect, stopping product recall issues. Teleflex benefits from advanced labeling and artwork management capabilities, all achieved because of the centralised cloud-based system from Kallik. End-users benefit from simplified processes and powerful features. These include a dedicated asset search engine, enhanced phrase and translation management, and end-to-end approval and audit trails.

"As a major medical device provider operating worldwide, teams working across all of our sites and facilities will be involved with the labeling process at some point, meaning standardised control and processes were simply non-negotiable for future success" - Brian Cannon, Senior Project Manager at Teleflex.

Another company benefiting from enterprise labeling software is Össur, a global leader in non-invasive orthopaedics. New EU MDR regulations meant their Kallik solution soon became instrumental in the successful completion of MDR compliance across its operations. With Kallik's software, Össur united all IFU phrases into a single centralized system, providing enhanced visibility over all IFU assets. This enabled Össur to identify key phrases that could be reused in multiple product IFUs. Even some of the more complex products had a higher rate of phrase reuse than expected. The reuse of key phrases has led to standardization of IFUs and a streamlining of product information.

“The team at Kallik went above and beyond to support us during the implementation of their labeling software. This was the reason why the change process project was so successful despite challenges posed by MDR regulations.” - Sigurður Gísli Karlsson, Global Product Manager at Össur.

Time to embrace technology


Embracing this technology can result in improved efficiency, minimized risks, and enhanced brand reputation for enterprise companies operating in regulated industries. What's more, it can often be quicker and easier to implement than many other enterprise solutions. Kallik’s labeling management software allows you to create, edit, approve, and produce compliant and accurate labels and artworks in a flash. Make your work more efficient, reduce manual hours spent, and minimise product reworks. All at a time when safety, cost, and compliance are paramount.