Ennov regulatory suite
Ennov Artwork
Artwork Management Software
- Reduces errors and accelerates time to market
- Centralized management of artwork files
- Advanced versioning and proofing tools
- Seamless integration with other Ennov Core Models
- 100% web-based, ready-to-use, and user-friendly
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
Aguettant Case Study
Cyrille JEUNE, Regulatory Affairs Systems Manager
Ennov Regulatory
World-Class Regulatory Content And Information Management
The Ennov Regulatory suite combines the power and flexibility of Ennov Doc, Ennov Dossier and Ennov Process to support the entire regulatory product lifecycle from the early planning of registration targets through product retirement. The Ennov Regulatory suite is an invaluable tool for regulatory activity planning, product registration management, dossier creation, dossier management and more.
Why Choose Ennov ?
Hundreds of corporate customers trust Ennov
Over 20 Years of experience providing software solutions for Life Sciences
250+ life science customers, 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
Available as cloud-based or on-premises deployment
You can switch between deployment options at any time.
We make you autonomous
System configuration and management require no IT skills.
Improved security and optimized performance
Data is hosted locally for total flexibility. Single-tenancy minimizes business interruptions.
Cloud-based or On Premises
Multi-Platform
