Labeling

Drive innovation across Healthcare Providers, Medical Devices, Pharma and Biotech industries and boost the efficiencies of healthcare eco system operations with high-quality software, engineering, industry domain and talent solutions developed by EZEN .

Business Challenges and Solutions

Existing Business Challenges Solutions
Product Recalls / Re-labeling Potential errors on labels such as:
  • Inaccurate set up of formulae for Expiration Dates, Barcodes
  • Spelling errors, wrong use of symbols and other crucial information will severely hit reputation, revenues and market share of life science companies

  • Implement robust quality control mechanisms
Multiple Regulatory Standards
  • The labels created for international product delivery, must comply with international regulatory requirements such as FDA, EMEA, MDD and other regional directives per respective regions
  • Data structuring
  • Interface design using templates / formats
Multiple Identification Standards
  • Multiple product identification standards are being used by Life Sciences companies (Such as GS1, HIBCC, EAN & UPC). This needs to be simplified / standardized for products delivered internationally where they need global supply chain tracking
  • Implementation of global standards like GS1 for unique product identification & tracking
Modified products / Local variations
  • In spite of efforts towards global standardization, there are region specific requirements for products such as language and regulatory requirements. Local variations of products is applied and verified by corporate and contract manufacturers, suppliers and distribution facilities
  • Implement region specific interface and filters to ERP systems to specific regions
  • Implement requirement base SOPs
Data Management
  • For Life Science companies the scope of labeling is beyond sticking labels. It is a combination of Instructions for Use (IFUs), managing technical & regulatory data, sterilization & material considerations etc
  • Centralized ERP system implementation leveraging and customization
  • Create SOPs at departmental and inter departmental level

EZEN's Product Labeling Services - 360o Support

Labeling Services
Consulting Services /Due Diligence System Migration and Integration Execution / Production Support
Testing/Evaluation
  • S/W Assessment
  • Mapping of existing S/W
  • Gap Assessment
  • System Verification
  • S/W Testing and Validation
  • HIBCC GS1 Barcode Implementation
  • Pilot Testing for Implementation
  • Master Template Validation
  • Label Testing
  • Artwork / Layout Design
  • Design Validation
Maintenance Services
  • System Upgrades Integration
  • System Selection
  • S/W Selection
  • System Migration
  • System Implementation
  • Labeling S/W Implementation
  • Label Change
  • Change Requests
  • Print Troubleshooting
Labeling Operations
  • Labeling System Assessment
  • Process Assessment
  • Change Impact Assessment
  • Site Implementation Planning
  • Data Migration and Validation
  • New Design and Development
  • Artwork and Graphics
  • Marketing Collaterals
  • Editorial Services
Quality and Regulatory
  • Regulatory Compliance Mgmt. (UDI compliance)
  • GS1 implementation
  • Change Mgmt
  • Documentation
  • Procedure updates
  • Quality Check & Label Proofing
  • Process Documentation & Control
Product Experience

Labeling & Artwork Services

Labeling

Labeling S/w Implementation

Template / Layout Design

New Label Creation

Existing Label Modification & Change Management

Creation of Work Instructions / IFUs

Label Proof Reading

Marketing Collaterals

Product Catalog / Brochures

Art Work Design
Editorial Services

Centralized framework for providing end-to-end Art work creation services as per the specifications and marketing requirements provided by client for all its product packages and labels

Complete Resource Management and job routing at the EZEN Resource Service Center (RSC)

Collaboration across stakeholders i.e., markets and sites for packaging and specification change requirements

Resource Profile
Software Tools