Ennov Doc for Regulatory
Effectively and efficiently manage Administrative, Non-Clinical, Clinical and CMC documentation with Ennov Doc—a fully featured EDMS.
- Full featured EDMS
- Configurable doc. life cycles
- Metadata-based document model
- Easy and intuitive searching
- Scalable and secure
- 21 CFR Part 11 compliant
The Regulatory Document Management Challenge
Authoring, reviewing, approving and tracking documents that are destined for global regulatory submissions can be a challenge. Submission teams across multiple departments and locations must collaborate effectively to ensure that timelines and agency commitments are met.
Storing documents on file shares across disparate locations and emailing them among team members is inefficient, impedes productivity and introduces risk. Regulatory Operations staff often needlessly spend time hunting for the correct version of documents – prolonging their tasks at hand and increasing the possibility of missed deadlines.
If these challenges sound all too familiar, our comprehensive full-featured Enterprise Document Management System, Ennov Doc for Regulatory can help you streamline document management processes and increase your operational efficiency.
Unified Access to All Documents
Ennov Doc for Regulatory provides a comprehensive solution to managing regulatory submission documentation. The document inventory is pre-configured in alignment with the DIA EDM Reference Model and includes all required domains, groups, sub-groups and artifacts.
Ennov Doc’s metadata-based document model provides the flexibility to adapt this model to your company’s organizational needs. Our intuitive suite of design utilities allow administrators to configure and manage the system without needing IT skills.
Ennov Doc’s scalability and security enables you to safely manage large volumes of documents – making it the perfect solution for global deployments.
Improved Productivity and Efficiency
Ennov Doc’s intuitive user interface and efficient search capabilities allow every employee to quickly locate and access the documents they require. The user-centric design and connectivity to Microsoft Office 365 and Google Drive improves user adoption, promotes collaboration and accelerates your return on investment.
Ennov Doc provides instant access to documents without requiring MS Office or Acrobat to be installed on the desktop. The integrated PDF Viewer increases security by providing read-access to documents from within application – eliminating the need to download an uncontrolled copy.
Integrated document templates, robust revision management, automatic document naming and numbering, inter-document relationships and electronic signature manifestation functionality make Ennov Doc for Regulatory the perfect solution to ensure your Regulatory submission documents are created on time and adhere to your authoring standards.
Manage Multiple Business Processes
Our customers use Ennov Doc Regulatory to support a wide variety of submission document types including adminstrative, quality, nonclinical, nonclinical report components, clinical and clinical report components. Ennov Doc’s high degree of configurability and seamless integration with our Business Process Management System (Ennov Process), our composite document and publishing system (Ennov Dossier) and our data visualization and reporting tools (Ennov Analytics) provides them the tools to achieve Regulatory operational excellence.
As an added benefit, Ennov Doc fully complies with the FDA’s 21 CFR part 11 requirements (electronic signature, audit trail, records management), making it a perfect fit for regulated industries such as pharmaceutical, biotechnology, animal health, medical device and others.
Core Capabilities
- Pre-configured document inventory
- Advanced life cycle management
- Flexible rights management
- Automatic PDF rendering and tag management
- Full text and metadata based searching
- Controlled printing, copy and paste
- Periodic review, expiration and archive management
- Office 365 and Google Drive connectivity
Key Features
- Integrated work list dashboard
- Configurable document types, workflows and views
- Automated email notifications
- Intuitive user interface
- Integrated PDF Viewer
- Composite document support
- 21 CFR Part 11 compliant
- 100% web-based
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
Regulatory
World-Class Regulatory Content and Information Management
The Ennov Regulatory suite has 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.
Regulatory
World-Class Regulatory Content And Information Management
The Ennov Regulatory suite has 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.
Cloud-based or On Premises
Multi-Platform
