Life science companies rely on NiceLabel
Label Compliance and the New European Medical Device Regulations (MDR)
Learn what medical device manufacturers need to do to prepare for compliance, the benefits of implementing a label management system and how label verification and print quality inspection aid compliance.
When: October 11th 2017
Recorded webinar available
Future-proof technology built for Life Sciences
NiceLabel’s label management system, LMS Enterprise, enables you to automate label printing by implementing a standardized integration with ERP, MES and other business systems at each site. By centralizing 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 seamlessly integrates with MES, ERP and PLM systems. This ensures your products are always labeled with the right master data coming directly from a central database. Company-specific business rules can be applied so that printing specifics are handled without costly changes to the ERP or MES system.
A document management system that streamlines compliance with regulatory requirements
LMS Enterprise includes a document management system (DMS) that was built for regulatory labeling. It’s a centralized digital label catalogue that controls and streamlines label lifecycle management by providing role-based access, document versioning, configurable approval workflows, and electronic records and electronic signatures (ERES) which are necessary to conform to FDA and EU regulations. A graphical “label comparison” tool helps consolidate label template variations and provides added quality assurance.
Electronic records and audit trails that exceed life science regulation requirements
LMS Enterprise provides a comprehensive set of audit trails, including full traceability and visualization of every printed label. 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 medical device manufacturers and includes a change and transport system for controlled and streamlined promotion of changes through different environments like development, quality assurance and production.
LiNA Medical reduces operating costs as part of UDI compliance
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 are empowered to respond to controlled label change requests without IT assistance.
- Increase productivity & reliability: remove manual tasks, streamline label lifecycle management and increase transparency of your labeling process in order to create a more effective and robust supply chain.
Rely on a professional services group with domain expertise
NiceLabel’s professional services group (PSG) can configure and deploy the NiceLabel label management system to 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.
More medical device resources
Medical device company achieves global UDI compliance while improving accuracy and reducing costs
Preparing for FDA 21 CFR Part 11 and EU GMP Annex 11
Global dental device manufacturer achieves compliant UDI labeling and Oracle integration
Validation of increasing importance for life sciences companies
The Class II UDI deadline is past. Enterprise labeling is the future.
How a small-medium sized medical device company responded to the new regulations