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“Labeling and packaging issues are the cause of 33 percent of medication errors, including 30 percent of fatalities.”   
                                               
Institute of Medicine of the National Academies

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enLabel Collaboration & Workflow Features

The enLabel application facilitates the workflow and control of the labeling process, while also electronically capturing all actions and change. This visibility and electronic auditing satisfies the needs of medical device manufacturers to be in compliance with FDA Part 11 regulations.

The application is accessed as a web page, allowing enLabel to provide a global collaboration platform to you without requiring the download or installation of additional software. A label designer may post a new template in Boston while a quality approver can review the template in Berlin and route it for printing in Los Angeles.

Designers and approvers access the Collaboration section to post templates and data, and to manage workflow. Reporting capabilities allow you to view all the actions performed on templates/labels, such as creation, updates and workflow activities including approval lifecycles.

enLabel offers a multitude of features that enhance packaging collaboration and workflow:

  • Flexible approval workflow cycles
  • 21CFR  Part 11 Compliance
  • Complete audit and history
  • Centralized data management, user configuration and  provisioning
  • Manage Data, Templates,& Labels electronically
  • Route for approval
  • Manage user permissions and access
  • Upload Control Access

Compliance Expertise FDA 21 CFR Part 11, EU MDD, OSHA, DOT, GMP, and UDI

 

Packaging & Labeling Experience
Label Design Features
Packaging Workflow
Packaging System Execution
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