Ennov regulatory suite

Ennov Artwork
Artwork Management Software

  • Reduces errors and accelerates time to market
  • Centralized management of artwork files
  • Advanced versioning and annotation tools
  • Seamless integration with other Ennov Core Models
  • 100% web-based and user-friendly
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The Challenges of Artwork Compliance in Life Sciences

Managing artwork for printed packaging materials in the life sciences industry presents numerous challenges. Companies face tight timelines and project management pressures while needing to collaborate efficiently among stakeholders. Ensuring compliance and minimizing errors is critical due to the complexity of approval workflows, resource management, and feedback loops. Fragmented handling of artwork files and versions often leads to disorganization, frequent errors, and delayed market launches. Organizations need a streamlined, compliant, and collaborative approach to manage their artwork processes effectively. 

Centralized Artwork Management on a Unified Platform

Ennov Artwork offers a powerful set of tools focused on content management, allowing content to be itemized, annotated, commented, and compared down to the pixel. Changes between versions can be clearly identified, and interaction with graphical content is intuitive. By integrating advanced versioning, annotation, and signature tools, Ennov Artwork ensures that all stakeholders work on the most current files, reducing the risk of errors. The platform is pre-configured and user-friendly, enhancing productivity and user adoption. 

Ennov Artwork streamlines the entire lifecycle of artwork, from initial requests to final approvals, ensuring full traceability and compliance with regulatory standards such as 21 CFR Part 11 and EU GMP Annex 11. Automated workflows and intelligent tools facilitate efficient project management, reducing time to market. Seamless integration with other Ennov Core Models provides a unified repository for Regulatory, Submission, Quality, and Supply data, enhancing overall data integrity and consistency. 

Improved Productivity and Efficiency

Ennov Artwork’s intuitive user interface and efficient search capabilities allow employees to quickly locate and access required documents. The platform provides instant access to documents, reducing the need for repeated downloads and ensuring that teams work on the most current files. Integrated document templates, robust revision management, automatic document naming and numbering, and electronic signature functionalities ensure artwork files are created on time and adhere to regulatory standards. 

Manage Multiple Business Processes

Ennov Artwork supports a wide variety of artwork projects, including new product launches, rebranding, and regulatory updates. Its high degree of configurability and seamless integration with Ennov’s other core models provides a comprehensive toolset for operational excellence. Ennov Artwork fully complies with FDA’s 21 CFR Part 11 requirements (electronic signature, audit trail, records management), making it ideal for regulated industries such as pharmaceutical, biotechnology, animal health, and medical devices.  

Core Capabilities

  • Configurable templates for global regulatory standard100% web-based platform for accessibility and ease of use
  • Life sciences expert solution offering full compliance
  • Integrated platform for seamless data management
  • Comprehensive audit trail for all regulatory activities

Key Features

  • Dynamic artwork file with metadata
  • Multi-media management and viewing: jpeg, PDF, MP4, MP3, HTML...
  • Versioning and comparison
  • Intuitive user interface for easy search and use
  • Automated notifications for regulatory milestones
  • Automated workflows for compliance management
  • Electronic signature and SSO

Ennovを選ぶ理由

Ennovを信頼する数百社の顧客企業

20年以上にわたるライフサイエンス分野におけるソフトウェアソリューションの提供経験

ライフサイエンス分野の顧客は250社以上、その他の業界も多数

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顧客満足度が非常に高く、98.5%のプロジェクトが期限内、予算内に納品されている

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クラウドベースまたはオンプレミスでの導入が可能

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