Powering the future of pharmaceutical labeling and marking
Rising competition, increasing government scrutiny and regulations, expiring patents and growing market pricing pressures – the current manufacturing landscape is a challenging one. In order to compete, pharmaceutical companies are compelled to identify ways to improve operational efficiency and reduce operating costs.
Labeling technology offers many opportunities for pharmaceutical companies to successfully tackle rising challenges. Download the white paper "Labeling Best Practice in a Challenging Manufacturing Landscape - A survival guide for pharmaceutical companies".
Life science companies rely on NiceLabel
Krka streamlines compliance
and label management
One solution for all your label and marking printers
NiceLabel technology enables pharmaceutical companies to use a single software platform for all printing devices and for all packaging and shipping, from primary to tertiary labeling. With NiceLabel, you can meet regulatory requirements faster, reduce labor costs, get product to market faster and avoid recalls related to labeling errors. The result will be a more agile manufacturing operation that will enable your company to meet current and future challenges and compete in an increasingly complex market environment.
Drug recalls have increased more than 65% over past ten years.
50% of pharmaceutical recalls are due to errors in product labeling or packaging artwork.
The average cost to distribute a recall notice is $8 million.
Product recalls, now occurring about 20 times / week in pharmaceuticals in the U.S. alone.
Future-proof technology built for Life Sciences
NiceLabel’s label management system, LMS Enterprise, enables you to automate label and direct marking printing by implementing a standardized integration with your Manufacturing Execution System (MES) at each site. By centralizing the master data and establishing a single source of truth, you can eliminate manual data entry errors, mislabeling and associated costs.
Integrate label printing with MES and ERP
LMS Enterprise includes an integration system with seamless support for Werum PAS-X, SAP and many other MES and ERP systems used in the pharmaceutical industry. This assures your products are always labeled or marked with the right master data coming directly from the central database. Company-specific business rules can be applied to assure printing specifics are handled without costly changes to the ERP or MES systems.
A document management system that streamlines regulatory requirements
LMS Enterprise includes a document management system (DMS) that was built for regulatory labeling. The DMS provides role-based access, document versioning, configurable approval workflows, electronic records and electronic signatures (ERES) necessary to conform to FDA and EU regulations. The DMS offers many other features built for life sciences, including a graphical “label comparison” tool help consolidate template variations and provide quality assurance. The DMS is a centralized digital label catalogue that controls and streamlines the entire label lifecycle management.
Electronic records and audit trails that exceed life science regulations
LMS Enterprise provides a comprehensive set of audit trails, including full traceability and visualization of every label printed or marked. Traceability extends beyond printing to include every change request and every system event, including user, location and timestamp information. Additionally, electronic PDF documents, reflecting physically printed labels, can be natively generated for submission to 3rd party content management or PLM solutions.
Change and transport system built for life sciences
LMS Enterprise fits seamlessly into the typical, multi-tier IT landscape of pharmaceutical companies and includes a change and transport system for controlled and streamlined promotion of changes through different environments (Development/Quality Assurance/Production).
Extend the system to your contract manufacturers
LMS Enterprise includes a unique “client-side” web printing system that you can use to extend the same high standard printing solution to your contract manufacturers, distributors and other business partners in minutes. By reducing relabeling and manual quality assurance checks, the system significantly improves the efficiency of the supply chain and reduces labor and inventory costs. The unique “client-side” technology empowers your business partners to configure and manage any of their existing printers.
Unite all your printers with one system
LMS Enterprise supports a wide range of industrial printers used in the pharmaceutical industry. These include label, print and apply, continuous inkjet, laser marking, thermal transfer overprinters and thermal inkjet. This enables you to work with one label management system that is capable of integrating all your label and direct marking printers with your organization’s MES and ERP systems.
Transform your labeling processes to accelerate growth
By modernizing your processes with the NiceLabel Label Management System (LMS Enterprise), you will:
- Reduce operating costs: less quarantine, less rework, less recalls and happier customers.
- Achieve quicker time-to-market: business users empowered to respond to controlled label change requests without IT assistance.
- Increase productivity & reliability: remove manual tasks, streamline label lifecycle management and higher transparency of your labeling process in order to create a more effective and robust supply chain.
- Strengthen collaboration and compliance: gain competitive advantage by modernizing and standardizing your label process, ensuring compliance and quality across teams, sites and external partners.
Rely on a professional services group with domain expertise
The NiceLabel Label Management System has the option to be configured and deployed via a professional services group (PSG) to speed up deployment and ensure that the system is implemented according to best practices. The PSG team can provide IQ, OQ and PQ validation packages and services to help meet your documentation needs and regulatory requirements.
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