Ennov RIM Description
Envision having all your regulatory details related to products, registrations, submissions, correspondence, and commitments consolidated in a single, easily accessible location. With Ennov RIM, companies in the life sciences sector can enhance their regulatory workflows, elevate data integrity, swiftly address crucial business inquiries, and efficiently fulfill requests from health authorities. Specifically designed for the oversight and monitoring of therapeutic product information and registration data, Ennov RIM is rooted in Ennov Process. Regardless of whether you are preparing for the introduction of a new product or managing adjustments to current registrations, Ennov RIM equips regulatory teams with essential information and tools to proficiently oversee product portfolios on a global scale. This comprehensive approach not only fosters compliance but also promotes strategic decision-making across the organization.
Ennov RIM Alternatives
RegDesk
RegDesk is the most comprehensive AI-enabled RIMS platform for Medical Devices, Pharmaceuticals, and IVD companies.
• Our proprietary Regulatory Intelligence for over 120+ countries is translated and accessible in a standard format. In addition, it provides alerts on evolving regulatory changes
• Our AI-powered Application Builder allows RA teams to prepare and publish global applications in 1/10th of the time
• Our Change Assessment capability helps RA teams understand the impact of the change(s) on an existing product(s) and the action required
• Our Distributor Collaboration provides seamless workflow solutions to interact, communicate, and share documents with external business partners
• Our Standards Management makes it easy for RA teams to search and manage not only international but also country-specific standards
• Our Tracking & Reporting functionality allows teams to track regulatory projects across the globe, receive renewal notifications, and generate reports on KPIs within seconds
For more information, visit our website.
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Qualio
Qualio unifies QMS workflows with real-time compliance intelligence — giving quality and regulatory teams one place to manage documentation, training, deviations, CAPA, audits, and regulatory obligations.
Where basic eQMS tools stop at record-keeping, Qualio continuously assesses quality data against FDA, ISO, and EU MDR requirements to show where compliance is drifting before it becomes a finding.
Key Capabilities
Document and change control
Training and competency management
Deviations, nonconformances, complaints, and CAPA
Internal/external audit and inspection management
Compliance dashboards and hotspot alerts
Product/site-level risk visibility and regulatory mapping
Rapid deployment and validation support
Business Outcomes
✔️ Audit ready in weeks
✔️ Inspection ready anytime — no fire drills
✔️ Lower total cost of compliance
✔️ Confident, risk-managed scaling
Designed for MedTech, pharma, and biotech companies in growth mode.
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Ennov Process
The Ennov platform has its own workflow engine, which provides advanced capabilities. Ennov Training, Ennov eTMF, and Ennov RIM use workflows. They enable the organization to control the sequence of tasks and data modification, while also providing visibility throughout the organization. Functional administrators can configure workflows using a graphical interface. To ensure consistency, coherence checks are performed when you save modifications. Ennov ensures that workflows are consistent and reliable. Each Ennov workflow comes with a configurable form. Dynamic sections allow data entry to be made easier by displaying or hiding fields depending on what field values have been entered (e.g., the type of Incident). The connected user can enter free text, select values from picklists, and add additional files as needed. To complete a workflow step, an electronic signature may be required.
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Ennov Regulatory Suite
Ennov Regulatory Suite is a world-class solution for regulatory content and information management. It is a unified, centralized and end-to-end solution that supports the regulatory information workflow, from the earliest stages through market authorization. This is a common principle that companies who strive to achieve regulatory operational excellence share. This is because they know that such a solution will allow them to drive harmonization and promote standardization, improve collaboration and ensure compliance, eliminate waste and reduce costs, accelerate product releases, and allow them operate and compete in global markets more effectively. Ennov Doc, Ennov Dossier, and Ennov Process combine to provide support for the entire regulatory product cycle, from early planning of registration targets to product retirement. The Ennov Regulatory Suite is a valuable tool for planning regulatory activity.
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Integrations
Company Details
Company:
Ennov
Year Founded:
1999
Headquarters:
France
Website:
en.ennov.com/regulatory-content-information-management/rim-regulatory-information-management/
Media
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Product Details
Platforms
Web-Based
Types of Training
Training Docs
Customer Support
Business Hours
Online Support
Ennov RIM Features and Options
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