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Getting your labels ready for EU MDR: Five steps to ensure your systems and processes are optimized for compliance
The date of application for the European Union Medical Device Regulation (EU MDR) is May 26, 2021. What do you need to know in order to be ready for the deadline? And how can you ensure that your labeling system and processes are MDR-ready?
We’ve prepared this brief guide to help you on the path to EU MDR-compliant labeling.
Make label changes faster while reducing the burden on IT
As an SAP user, you have the platform in place to take advantage of the efficiency gains that digitization offers. But what about labeling? Legacy labeling approaches are overly dependent on IT and label change requests can take weeks, negatively impacting customer satisfaction and time to market. A labeling system that fits seamlessly with your SAP environment and that’s built for purpose; i.e. for designing, printing and maintaining labels; creates a truly agile labeling process.
Find out how a modern label management system helps SAP users digitize quality assurance, increase accuracy and extend labeling across the supply chain.
Is it finally time to solve the supplier labeling dilemma?
We believe that the key to consistent, standardized supplier labeling lies in the Cloud. You can argue that there has never been a use case as well suited for the Cloud as supplier labeling. Cloud makes it possible for you to store your label information centrally. You control the entire label management process, and you extend that label process to your suppliers over the Web.
Preparing ticketing and tagging for a post-Amazon world
The apparel and garment industry is under pressure. The disruptions that the first Industrial Revolution brought to garment manufacturing required retailers to embrace technology, and with globalization came the need for retailers to adjust business models and go-to-market strategies. Then came the infamous Amazon effect, and the nature of the game changed.
How the industrial Internet impacts SAP users' label production process
The industrial Internet has created an increasingly challenging environment for SAP users. Companies are under pressure to digitally transform in order to compete. Legacy, manual labeling processes must give way to a standardized and streamlined approach enabled by modern label management systems. In this whitepaper, learn what digital transformation of on-demand factory labeling can mean for SAP users and how it enables companies to significantly reduce costs and get faster-time-to market.
How Modern Label Management Helps Medical Device Manufacturers Compete in a Challenging Marketplace
Increasing regulations and competition are combining to create a perfect storm of pressure on device manufacturers to fundamentally change their business operations. Forced to balance the constant price pressure and need for increased operational efficiency with the ever-increasing demands for quality, smaller medical device manufacturers find themselves struggling to compete against the corporate mastodons of their sector. Yet many manufacturers are waking up to the competitive secret weapon that is modern label management. This white paper outlines four key challenges facing medical device manufacturers and demonstrates how leveraging modern label management can help these companies successfully tackle these challenges and create operations that are optimized for competing in a global marketplace.
EU MDR and IVDR: Uncovering Hidden Cost Savings While Complying with Device Traceability and UDI Requirements
This white paper will outline the significant challenges medical device companies may have as they comply with the European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). It will also explore the device traceability portion of the MDR and IVDR and uncover lessons learned from the United States Food and Drug Administration (FDA) Unique Device Identification (UDI) regulation. Finally, it will provide a list of actionable steps that medical device manufacturers can take to ensure device traceability compliance, and how they can reduce operational costs along the way.
Adopting Next Generation Labeling Technology Enhances Enterprise Agility and Reduces Costs
The new generation of label management solutions gives many enterprises a strong opportunity to reduce costs, improve agility, and reduce the risk of production shutdowns and non-compliance with labeling requirements. These benefits are delivered because modern label management solutions enable organizations to consolidate and automate redundant label development and maintenance tasks that today are typically carried out by a variety of developers and operations staff at each facility that produces labels.
Labeling Best Practice in a Challenging Manufacturing Landscape - A survival guide for pharmaceutical companies
The number of challenges for the global pharmaceutical industry is perhaps higher than ever before. Competitive pressures, new stipulations from governments and regulators, products coming off patent and market pricing pressures have combined: pharmaceutical companies are increasingly obliged to seek competitive advantage through efficiency and cost reduction measures.
Learn how Labeling technology offers many opportunities for pharmaceutical companies to successfully tackle rising challenges. Discover how a modern label management system can help the pharmaceutical industry improve product quality, achieve quicker time-to-market, improve productivity and reduce operating costs.
How food and beverage companies can digitally transform labeling to accelerate growth
The food and beverage industry is under pressure from tighter margins, global competition and increasing regulatory compliance requirements. To compete in such a challenging environment, companies must take advantage of new technologies to reduce costs, increase productivity, avoid product recalls and ensure data quality. Improved agility, increased productivity and better quality management are just a few of the gains that food and beverage manufacturers are finding from the introduction of a modern label management system.
Preparing for FDA 21 CFR Part 11 and EU GMP Annex 11 (A Technical Compliance Guide for Life Sciences)
Drug and medical device manufacturers as well as companies in other FDA regulated industries are required to provide electronic records and signatures as a reliable equivalent to paper records. This white paper examines the FDA and EU regulatory standards and outlines how NiceLabel solutions ensure proper label life cycle compliance. You will learn how NiceLabel integrates the labeling required for life sciences regulations with customers’ existing workflows and business information systems including Oracle, SAP, or another ERP system.
This paper will provide companies with varying printing and administrative workflows information on the software tools they need to comply with FDA and EU regulations.