Ennov Artwork
Artwork Management Software
Simplify artwork management and accelerate time to market with a centralized, compliant, and collaborative solution.
- Centralized repository with versioning, annotation, and comparison tools
- Integrated with Regulatory, Quality, Submission, and Supply data
- Workflows and dashboards streamline approvals and reduce delays
- Compliant with 21 CFR Part 11 and EU GMP Annex 11
- Reduce errors and accelerate time to market
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, proofed, 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, proofing, and comparison tools, Ennov Artwork ensures that all stakeholders work on the most current files, reducing the risk of errors. The platform is pre-configured, ready-to-use, 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, intelligent tools, and integrated dashboards facilitate efficient project management and activity monitoring, 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 standards
- 100% web-based, ready-to-use platform for accessibility and ease of use
- Life sciences expert solution offering full compliance
- Integrated platform for seamless data management
- Comprehensive audit trail and activity dashboards for all regulatory activities
Key Features
- Dynamic artwork file with metadata
- Artwork proofing and comparison
- Versioning and annotation
- Intuitive user interface for easy search and use
- Automated notifications for regulatory milestones
- Automated workflows for compliance management
- Electronic signature and SSO
The Impact of Ennov RIM at Foghorn Therapeutics
Efficient regulatory information management can be complex. Your software shouldn’t be.
Aguettant Case Study
“It’s really nice to work with a software provider that shows a great deal of innovative spirit, has great ambition and is proactive. Above all, I really appreciate Ennov placing particular emphasis on the customer’s user experience.”
Cyrille Jeune,
Regulatory Affairs Systems Manager

Septodont Case Study
“With more than 1500 MAAs in 150 countries, we face a real productivity challenge. With Ennov, we have been able to issue 400 dossier in just 18 months. For the first time, our users are experiencing tremendous time savings when locating documents.”
Aurélie Becquet,
Regulatory Affairs
World-Class Regulatory Content and Information Management
A Regulatory suite with the power and flexibility to support the entire regulatory product lifecycle from the early planning of registration targets through to product retirement.
It is an invaluable solution for regulatory activity planning, product registration management, dossier creation, dossier management and more.
Why Choose Ennov
Over 500,000 users trust Ennov
Over 500,000 users trust Ennov
- Over 25 years of experience providing software solutions for Life Sciences and 450+ Life Science customers, with many more in other industries.
- Modern architecture and interface 100% web-based. Highly scalable. User-centric design.
- Our commitment to your success Very high customer satisfaction, 98.5% of projects delivered on time and within budget.
Providing you freedom of choice
Providing you freedom of choice
- Available as cloud-based or on-premises deployment, you can switch between deployment options at any time.
- System configuration and management require no IT skills, making you fully autonomous
- Improved security and optimized performance. Data can be hosted locally for total flexibility. Single-tenancy minimizes business interruptions.
