Audience
Life science industries looking for a regulatory content and information management software
About Ennov Regulatory Suite
Ennov Regulatory Suite, a world-class regulatory content and information management is a unified, centralized, end-to-end solution that is robust enough to support the regulatory information workflow from the earliest stages of research and development through market authorization. It is a common principle shared by companies striving to achieve regulatory operational excellence. These companies understand that an such a solution will help them drive harmonization, promote standardization, improve collaboration, ensure compliance, eliminate waste, reduce costs, accelerate product release and allow them to operate and compete more effectively in global markets. 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.
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Company Information
Ennov
Founded: 1999
France
en.ennov.com
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Ennov Quality Suite
Ennov Quality Suite. A comprehensive QMS to improve efficiency and ensure compliance. Ennov Quality Suite Ennov’s Quality suite combines the power and flexibility of Ennov Doc, Ennov QMS, Ennov Report and Ennov Training to create a quality management solution that not only improves operational efficiency but also ensures compliance with industry standards such as 21 CFR Part 11, GxP and ISO. Ennov Quality provides a predefined inventory of quality documentation, processes and workflows that are based on accepted industry standards and best demonstrated practices. This allows Ennov Quality customers to get their system into production quickly and start realizing their return on investment. Ennov Quality, like all Ennov solutions is very easy to configure and requires no IT skills. An intuitive and unified content and information management platform to support and enrich the entire Life Sciences product life cycle. Our comprehensive QMS improves operational efficiency
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Ennov RIM
Imagine all of your regulatory information regarding products, registrations, submissions, correspondence and commitments in one centralized place accessible from anywhere. With Ennov RIM, life sciences companies can streamline their regulatory processes, improve their data quality, quickly answer business-critical questions and effectively respond to health authority requests. Ennov RIM is a purpose-built application (based on Ennov Process) for the management and tracking of therapeutic product details and registration information. Whether you are planning the launch of a new product or handling variations to existing registrations, Ennov RIM provides Regulatory personnel with the key information and functionality to effectively manage your product portfolios worldwide.
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Ennov Dossier
The efficient production of PDF publications is an important aspect of a document management operation. Having a single publishing solution that can effectively produce PDF reports and manuals from the source documents contained within your EDMS provides a distinct advantage in terms of flexibility, training and total cost of ownership. Ennov Dossier is complete and scalable dossier management and PDF publishing solution that is suitable for document management operations of all sizes. The software is comprehensive, flexible, intuitive and easy to use. Ennov Dossier provides the ability to build, manage, publish and archive PDF publications using the native capabilities found within Ennov Doc. This eliminates the fragmented and inefficient processes of locating, copying and uploading the documents that you need for your publications, providing a harmonized and seamless dossier publishing solution.
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Veeva Vault RIM
End-to-end regulatory information management on a single platform. The Vault RIM Suite streamlines global regulatory processes on a single, cloud-based platform, enabling life sciences companies to improve visibility, data quality, and agility. Respond faster to changing regulations and increase process efficiency from submission planning to publishing. Coordinate regulatory efforts across HQ, affiliates, and partners within a single RIM system. Ensure teams are developing reliable regulatory content with high data integrity. Veeva Vault Registrations manages product registration data worldwide, including registration status, variations, and health authority interactions. Veeva’s flexible data model accommodates IDMP data points and will continue to support evolving regulatory data standards. Veeva Vault Submissions streamlines submission planning through approval by automating regulatory process steps.
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Product Details
Platforms Supported
SaaS
Windows
Training
Live Online
In Person
Support
Phone Support
24/7 Live Support
Ennov Regulatory Suite Frequently Asked Questions
Ennov Regulatory Suite Product Features
Compliance
Archiving & Retention
Audit Management
Compliance Tracking
FDA Compliance
ISO Compliance
Incident Management
Risk Management
Version Control
Workflow / Process Automation
Artificial Intelligence (AI)
Controls Testing
Environmental Compliance
HIPAA Compliance
OSHA Compliance
Sarbanes-Oxley Compliance
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