The next generation publishing solution that simplifies, automates, and accelerates the entire regulatory publishing process
Offering the richest functionality, powerful tools, and a single, easy-to use interface, Liquent InSight Publisher enables you to quickly and easily create, review, and amend regulatory dossiers, and submit them for market approval.
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Easy-to-use Web interface Liquent InSight Publisher has a rich, easy-to-use Web interface that requires no ActiveX controls, or Java applets. It does include separate desktop tools that enable linking and exporting content from the DMS to write to removable media. It also contains a self-auditing database that has been specially designed for 21 CFR Part 11 compliance, as well as audit trail configurable security features and validation scripts.
Easily create, manage, and keep track of submissions Liquent InSight Publisher gives you all the tools and functionality you need to create, send, keep track of, and amend a submission to a regulatory authority for market approval. Through a single solution you can:
- Access eCTD templates for each region in which you are submitting
- Drag and drop multiple documents to speed up the submissions process
- Keep track of documents across multiple applications
- Generate a Publishing Readiness report that lists missing documents, renditions, and eCTD metadata
- Store administrative information that's in XML format in region-specific folders
- Create links between documents using a toolbar in Microsoft Word and Acrobat and then manage the links externally from the documents
- Choose between publishing all your content and XML files in one go, publishing selected content and XML files only, or publishing just XML files
- Integrate Liquent InSight Publisher with existing ERDMS systems such as Liquent InSight Foundation.
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Using Liquent InSight Publisher, you can:
- Use Submissions Wizards to streamline the initiation of submissions that comply with ICH, Japanese, EU, US, STF, and Canadian specifications.
- Quickly create all the necessary components for a compliant eCTD submission, including the required ICH, STF, and regional XML files, the correctly named leaf files and folder structures, and any requisite navigation aids
- Easily manage subsequent amendments, supplements and variations to your submissions using intuitive right-click menu options and simple drag and drop features, making all updates in the context of the full application
- Create multiple submissions in multiple regions using comprehensive, built-in templates
- Automatically transform documents in multiple file formats into enhanced PDFs with bookmarks and hyperlinks
- Move seamlessly from product registration management to submissions management to publishing your submission to tracking your data, by implementing Liquent InSight Publisher with the complete Liquent InSight Suite of solutions
- Enhance your organization's efficiency, reduce your time to market, and be assured of compliance with the latest regulatory guidelines and specification
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