A smarter, faster, unified way to work across Regulatory, Quality, Clinical, and Pharmacovigilance, now with powerful, built-in AI.
Ennov 11.0 is here, and it’s our most advanced release yet. It brings AI into the heart of the Ennov platform, introduces a new global homepage as your all-in-one cockpit, and delivers targeted enhancements across every domain to help regulated teams work faster, stay compliant, and focus on higher-value tasks.
AI Integrated into the Ennov Platform
Ennov 11.0 introduces powerful, built-in AI capabilities designed specifically for regulated life sciences environments. These features work directly within the platform, no external tools or integrations, ensuring full traceability, security, and compliance:
- The Ennov AI Chatbot acts as your personal assistant inside the platform. It answers questions about your documents, surfaces relevant records, and suggests next actions. Ask about a submission status, find related CAPAs, or locate the latest SOP version in seconds — without leaving Ennov.
- For Regulatory teams: Auto-classify eCTD documents and streamline agency correspondence, eliminating manual categorization that slows submissions. Ennov AI is here to help accelerate your time to market.
- For Quality teams: Generate compliance quizzes from SOPs in seconds, turning training from a bottleneck into an automated process. Ennov AI reduces the risk of non-compliance drastically.
- For Pharmacovigilance teams: Extract and summarize case narratives instantly, so reviewers can focus on analysis instead of data gathering. Ennov AI saves you time so you can focus on value-added work.
All AI actions are fully traceable, validated, and secure, designed for regulated environments from day one.
*Ennov AI is available as an optional licensed module.
A New Homepage: Your Powerful, All-In-One Cockpit
The Ennov unified platform gives teams a single place to see their data, documents, and ongoing work. Ennov 11.0 takes that to the next level.
A new, powerful global homepage that brings documents, tasks, signatures, reviews, and messages together in a single, centralized view in a completely customizable way. Here are the biggest benefits:
- Role-based widgets that surface the KPIs and updates each user needs most.
- Actionable queues that let users complete signatures, reviews, and escalations in one place.
- Inline and batch actions that accelerate reviews and routine tasks.
- Real-time indicators that guide users toward accurate, compliant work.
This unified homepage gives teams a clear entry point into your work, helping you stay organized and aligned across processes.
Enhancements Across Regulatory, Quality, Clinical and PV
Every improvement in Ennov 11.0 reflects the feedback and collaboration of our customers. This release reinforces our long-standing commitment: to deliver modern, intuitive, and reliable technology that supports regulated teams around the world.
- Real-time compliance indicators catch issues before they become audit findings.
- Complete traceability follows every document, task, signature, and decision.
- Audit-ready documentation is generated automatically as work progresses.
Regulatory teams gain drag-and-drop dossier reuse across regions, eCTD import capabilities, and an Approved View that instantly highlights authorized content for global submissions.
Quality teams benefit from auto-generated training quizzes from SOPs, linked Quality and Training records, and real-time indicators that help minimize user error during critical processes.
Clinical teams get fully integrated RTSM and EDC with default e-signatures, separate TEST/PROD environments, and interactive dashboards that turn study data into decisions.
Pharmacovigilance teams access AI-driven case summarization and prioritization that highlight high-risk signals and integrate seamlessly with existing workflows, no retraining required.
See What’s Next
Join us at the Ennov User Meeting – Denver, April 27–29, 2026 to connect with peers, preview upcoming innovations, and shape the next version of Ennov.
Don’t miss your chance to be part of the conversation.
New to Ennov?
More than 450 life sciences organizations choose Ennov to support their Regulatory, Quality, Clinical, and Pharmacovigilance activities.
Discover how Ennov 11.0 enhances collaboration, efficiency, and compliance across teams.
