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enLabel Global Services yours.

Company description

enLabel Global Services is a life sciences software company specializing in packaging and labeling solutions for highly regulated global industries. Their mission is to make complex packaging simple and compliant, offering an integrated software platform that manages the entire end-to-end packaging lifecycle — from label design and approval through printing and audit — all within a single unified system.

enLabel serves enterprise clients operating under stringent regulatory frameworks including FDA, MDD, EU, APAC, OSHA, DOT, GMP, UDI, GHS, and CLP requirements. As a GS1 US Solution Provider, the company is positioned to support organizations that must achieve zero-defect packaging while maintaining global compliance across multiple markets and jurisdictions.

Core Platform Offerings

• Integrated Packaging Management (IPM): The flagship platform described as the world's first end-to-end global packaging and labeling solution. IPM enables clients to create, monitor, control, change, print, and audit all packaging materials within one single software platform with global accessibility. It connects all global packaging personnel in real-time, including label designers, approvers, administrators, and manufacturing operators.
• e-Labeling / eIFU: enLabel's electronic Instructions for Use (eIFU) software allows clients to publish product information and media to a dedicated, compliant website for customer access. Supported content types include Instructions for Use, labels, manuals, brochures, videos, and 3D CAD files.
• enLabel Cloud/SaaS: A cloud-based deployment option for the enLabel platform, enabling flexible and scalable access to packaging management capabilities.

Key Platform Capabilities

• Design Module: A robust, feature-rich module that standardizes corporate labeling and branding, ensures consistency in label and template creation, and eliminates data redundancies.
• Workflow Module: An innovative approval management module that allows users to send, view, edit, approve, and reject finished labels from any location worldwide, eradicating manual approval processes.
• Execution Module: Enables manufacturers to print, reprint, and relabel over the web, sending finished files to any native print driver globally, optimizing the printing process across the enterprise.
• Audit and Reporting: Provides complete audit reporting and enterprise-wide visibility, with integration support for SQL and Oracle environments.
• Automated Migration: Offers the world's only automated migration process for packaging and labeling, enabling clients to fully transition pre-existing digital assets from in-house databases to the IPM platform in record time.

Compliance Capabilities

• Unique Device Identification (UDI): enLabel facilitates compliance and deployment of an integrated UDI solution, providing control and visibility for content management throughout manufacturing and distribution, as well as data submissions to GUDID, GDSN, and other third-party sources.
• Title 21 CFR Part 11: The platform is built to support compliance with FDA's electronic records and electronic signatures regulation.
• Globally Harmonized System (GHS/CLP): Supports compliance with GHS and CLP labeling standards for hazardous materials.
• Localization: Capabilities to support global labeling localization requirements across multiple regions and languages.
• enLabel provides Compliance Subject Matter Experts to guide clients through project planning, deployment, and validation.

Professional Services

• Software Development Life Cycle (SDLC) support and best practices guidance for packaging and labeling implementations.
• Consolidation and Migration services to streamline and transition existing packaging data and assets.
• Implementation and Training services to ensure successful platform adoption.
• Verification and Validation services to meet regulatory requirements.
• 24/7 Support to provide ongoing assistance to global enterprise clients.

enLabel Global Services combines its IPM software platform with deep regulatory expertise and a comprehensive suite of professional services, making it a comprehensive partner for life sciences and other highly regulated organizations seeking to eliminate packaging errors, guarantee product safety, and expedite time-to-market on a global scale.

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Software attributed to enLabel Global Services

• IPMView
• eIFUView

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