Ennov regulatory suite
Ennov InSight Publishing
Streamline Your Regulatory Publishing with Ease and Efficiency
- Accelerates creation of compliant submissions
- Supports global eCTD specifications, including 4.0 and eSubmissions
- Comprehensive paper features for ROW and report publishing
- Integrated wizards to simplify regional requirements
- Smart bookmarking and linking tools
- In-built validation checks for compliance assurance
- User-configurable landing page and favorites function
- Easy drag-and-drop content linking from multiple document locations
Introduction
Ennov InSight Publishing is a comprehensive solution designed to simplify and streamline the regulatory publishing process. It enables life sciences companies to create, manage, and submit regulatory documents in any regulatory format, ensuring compliance with regional requirements. With advanced tools and an intuitive user interface, InSight Publishing helps organizations meet deadlines and maintain the highest standards of data quality.
The Challenge of Regulatory Publishing
Regulatory publishing in the life sciences industry is a complex and time-consuming task, requiring meticulous attention to detail and compliance with diverse regional standards. Companies often struggle with managing multiple formats, tracking submission lifecycles, and ensuring all documents are up-to-date with the latest regulations. Without an efficient system, these challenges can lead to delays, increased costs, and potential compliance issues, ultimately leading to revenue loss by hindering a product’s market entry and lifecycle management.
Solution Overview: Why Ennov InSight Publishing is Better
Ennov InSight Publishing stands out as a leading solution for regulatory publishing due to its comprehensive functionality and user-friendly design. It supports electronic (eCTD and NeeS) and paper submissions through a common interface, allowing users to create multiple submissions for different regions with ease from the same assembly. The platform’s built-in templates and wizards guide users through the creation process, reducing errors and ensuring compliance with regional standards.
Advanced Tools and User Interface
InSight Publishing offers smart linking and bookmarking tools, making it easy to navigate and organize submission documents. The integrated validation tools ensure that submissions meet the required specifications, providing comprehensive interactive reports for corrective action. The user-configurable landing page and favorites function allow users to personalize their experience, improving efficiency and ease of use.
Implementation and Integration
The platform integrates seamlessly with existing document management systems like Veeva and Documentum and supports drag-and-drop functionality for easy content assignment. The expert team behind InSight Publishing brings over 100 years of experience in regulatory information management, ensuring a successful implementation tailored to your organization’s needs.
Core Capabilities
- Accelerated creation of compliant submissions
- Global for eCTD, NeeS, and paper submissions compliance
- Integrated wizards for step-by-step guidance
- Smart bookmarking and linking tools
- Built-in assembly templates for all regions
- User-configurable landing page and favorites
- Drag-and-drop integration with document management systems
Key Features
- Comprehensive and configurable data model
- Iterative publishing capabilities
- Validation tools for eCTD and NeeS submissions
- Creation of ICH STF and regional XML files
- Manage amendments, supplements, and variations
- Common user interface for all submission types
- Export functionality for query results
Ennov Regulatory
世界最高水準の規制コンテンツと情報管理
Ennov Regulatory Suite は Ennov Doc、Ennov Dossier、Ennov Process の機能と柔軟性を組み合わせ、登録目標の初期計画から製品の廃止まで、規制当局の製品ライフサイクル全体にわたってサポートするものです。Ennov Regulatory Suiteは、規制当局の活動計画、製品登録管理、資料作成、資料管理などにおいて非常に有用なツールです。
Ennovを選ぶ理由
Ennovを信頼する数百社の顧客企業
20年以上にわたるライフサイエンス分野におけるソフトウェアソリューションの提供経験
ライフサイエンス分野の顧客は250社以上、その他の業界も多数
最新のアーキテクチャとインタフェース
WEBベース100％. 高い拡張性. ユーザー重視の設計
お客様の成功のために
顧客満足度が非常に高く、98.5%のプロジェクトが期限内、予算内に納品されている
お客様の選択の自由を尊重
クラウドベースまたはオンプレミスでの導入が可能
配置オプションの切り替えはいつでも可能
お客様の自主性を尊重
システム構成および管理に関するITスキルは不要
セキュリティの向上とパフォーマンスの最適化
データはローカルに保存されるが、柔軟性に富む。シングルテナントであるため、業務の中断を最小限に抑えられる
クラウドベースまたはオンプレミス
マルチプラットフォーム
