enLabel Global Services
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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

enLabel Global Services About enLabel Packaging & Labeling Experience IPM Platform Packaging & Labeling Solutions Packaging & Labeling Services Packaging & Labeling Resources

Core Competencies

The core competencies of enLabel Global Services reflect the history and ongoing development of our company.

enLabel's clients benefit from a knowledgeable team of professionals with extensive experience in technology, supply chain, manufacturing, compliance and quality assurance. Professional services include advisory, regulatory, compliance, globalization, managed services and technology. The enLabel commitment to superior service moves beyond execution and deployment to long-term service and support. Successful implementations are a testimony to enLabel Global Services effective system design skills. The enLabel project management team is handpicked to match each project and works closely with clients, guided by enLabels 7C's methodology to ensure success. The enLabel collaborative process, known as 7 C's begins with the client’s executive level commitment. Packaging systems assessment and strategic planning for Integrated Packaging Management includes forecasting and budgeting analysis.

  • Technology: enLabel's roots go back to its partner company, Integrated Software Design, which conceived and introduced the world's first PC based electronic labeling system in 1982 and has since successfully implemented over 4,500 packaging and labeling systems within the life sciences, manufacturing, chemical, retail, education, financial and electronics industries.

  • Supply Chain: enLabel has extensive experience in the supply chain area. The company's solutions provide manufacturers with the ability to share their requirements and packaging at low or no cost with suppliers worldwide.

  • Manufacturing: enLabel's track and trace solutions enable manufacturers to track product components from raw material to shipment thereby eliminating errors and reducing the risk for product recalls.

  • Compliance: enLabel defines and executes IPM strategies for the most stringent quality and regulatory programs to comply with national and international regulations, including FDA, EU, DOT, OSHA, GMP and ISO. enLabel's validated IPM solutions provide a 100% guarantee for full regulatory compliance by eliminating the need for manual data capture, preventing errors in product identification and assembly and improving overall quality procedures. The company provides validation, verification and full audit services.

  • Quality Assurance: The enLabel team has been developing custom software products for regulated industries for over two decades, with considerable effort focused on FDA, OSDA, DOT, ISO, GMP, and EU requirements. The company's software is designed based on user feedback and requirements and is structured to follow the Integrated Software Development Life Cycle (ISDLC) process.

enLabel Experience

Assessment & Strategic planning
  • Forecasting
  • Budgeting
System Design
  • Modularity
 Project Management
  • Thorough Documentation
  • Strict Quality Control
Quality, Methodology & Processes
  • Proprietary Methodology
  • Deadline setting
Execution & Deployment
  • On-Time Delivery
  • On-site Installation
 enLabel Professional Services
  • Technical Support
  • Training

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

 
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