Introducing NextGen eDQR.
NextGen eDQR – A Comprehensive Solution for Efficient Authoring and Archival of Development, Quality, and Regulatory Documents.
Cloud Deployment
On-Premises Deployment
KEY BENEFITS
Accelerate Your Document Management with NextGen eDQR: Boost Efficiency and Ensure Compliance
Document Creation and Approval
Simplify the process of creating, authoring, reviewing, and approving regulatory documents with eDQR.
Ensure Regulatory Compliance
Meet the requirements of Health Authorities by adhering to submission formats such as CTD, eCTD, ACTD, and more.
Centralized Submission Libraries
Organize and access submission-specific libraries for efficient document management.
Document Reusability
Easily reuse documents across different submissions, saving time and effort in document creation.
Comprehensive Document Management
Maintain control over approved and unapproved documents throughout their lifecycle.
Secure Document Repository
Store and access documents securely, ensuring data integrity and confidentiality.
Advanced Automation
Benefit from features like auto-synchronization and auto-save, reducing manual effort and minimizing errors.
PDF Rendering
Convert documents to meet Health Authorities’ requirements with a single click, ensuring compatibility and accuracy.
Effective Workflow Management
Streamline the document workflow, from authoring to archival, ensuring smooth collaboration and accountability.
Web-based Access
Access the eDQR software from anywhere, at any time, for convenient and efficient document management.
NextGen eDQR FEATURES
Experience the NextGen eDQR
eDQR’s key features enable efficient and streamlined document management for regulatory submissions.
Submission Libraries
Create submission-specific libraries to efficiently organize and manage documents related to regulatory submissions. Access and retrieve documents specific to each product or submission, ensuring accurate and streamlined document management.
Submission Format
Support various dossier formats such as CTD, eCTD, ACTD, and more, ensuring compliance with Health Authorities’ requirements. Seamlessly handle different submission formats, simplifying the preparation and submission process.
Document Reuse
Access and reuse documents across multiple submissions, eliminating the need for redundant document creation. Save time and effort by leveraging existing documents, ensuring consistency and accuracy across submissions.
Documents Lifecycle
Maintain a complete lifecycle record of both approved and unapproved documents, tracking their progress and status. Effectively manage document versions, revisions, and updates, ensuring compliance and document integrity.
Secure Repository
Store documents in a secure repository, providing controlled access and maintaining data confidentiality. Access documents securely anytime and anywhere, ensuring that only authorized individuals can view and modify them.
Advanced Automation
Benefit from auto-synchronization and auto-save features, reducing manual effort and minimizing the risk of data loss. Automate routine tasks, improving efficiency and allowing users to focus on critical aspects of document management.
PDF Rendering
Convert documents to PDF format with a single click, ensuring compliance with Health Authorities’ specific requirements. Generate PDFs that meet the necessary formatting standards, facilitating the submission process and ensuring document compatibility.
Workflow Management
Implement an effective workflow system that guides the document authoring, review, and archival processes. Enable seamless collaboration and task assignment, ensuring efficient progress tracking and timely document completion.
Document Versioning
Track and manage document versions, including comments, review changes, approvals, and other modifications. Maintain a clear audit trial of document revisions, facilitating transparency and accountability within the document management process.
Web Based Software
Access the software from anywhere, at any time, through a web-based interface. Enjoy the flexibility and convenience of managing documents remotely, facilitating collaboration and productivity across teams and locations.
Get cost-effective document management with eDQR’s flexible pricing plans
Take control of your document management process with confidence and maximize the value of your investment with eDQR. Our transparent model, you can easily understand and budget for the software, eliminating hidden costs and unexpected expenses.
Frequently Asked Questions
NextGen eDQR is a document management solution designed to support the authoring, review, approval, organization, and archival of development, quality, and regulatory documents. It helps pharmaceutical teams manage submission documents, maintain version histories, reuse content across submissions, and coordinate document workflows throughout the document lifecycle.
NextGen eDQR supports dossier formats including the Common Technical Document (CTD), electronic Common Technical Document (eCTD), and ASEAN Common Technical Document (ACTD). These formats help organize regulatory information for submission to health authorities. Organizations should confirm that the software configuration meets the specific technical requirements of their intended submission destination.
NextGen eDQR provides centralized, submission-specific document libraries that allow teams to organize, retrieve, and manage files associated with individual products or submissions. A centralized repository helps users maintain access to relevant documents, reduce scattered file storage, and support consistent document handling across regulatory and quality workflows.
Yes. NextGen eDQR includes document reuse functionality that allows existing documents to be accessed and reused across multiple submissions. This can reduce repetitive authoring work and help maintain consistency between dossiers. Reused content should still be reviewed and updated to reflect the relevant product, market, submission requirements, and current approved information.
NextGen eDQR supports document versioning and lifecycle tracking for approved and unapproved documents. Its features include tracking revisions, comments, review changes, approvals, and document status. These records help teams understand document history, maintain accountability, and identify the appropriate version during regulatory submission preparation and ongoing document maintenance.
Yes. The software supports workflows covering document authoring, review, approval, and archival. Workflow management helps assign tasks, coordinate collaboration, and track progress toward document completion. These capabilities can help Regulatory Affairs, Quality Assurance, and R&D teams manage responsibilities and monitor documents as they move through internal review and approval stages.
NextGen eDQR includes PDF rendering functionality that converts documents into PDF format. The feature is intended to help users prepare documents according to applicable health authority formatting requirements. Teams should verify the resulting PDF’s technical properties, readability, and destination-specific submission requirements before including it in a regulatory dossier.
The NextGen eDQR page identifies both cloud deployment and on-premises deployment options. This gives organizations deployment models to consider based on their infrastructure and document management needs. Before implementation, companies should confirm hosting arrangements, access controls, security responsibilities, system requirements, and any applicable internal IT or compliance requirements.
NextGen eDQR describes a secure document repository with controlled access, intended to restrict document viewing and modification to authorized individuals. Its document lifecycle and versioning features also support controlled handling of files. Organizations should assess the configured permissions, security controls, audit-trail capabilities, and validation needs before using the system for regulated records.
NextGen eDQR supports document lifecycle tracking for approved and unapproved documents, including version histories, revisions, comments, review changes, and approvals. These capabilities help pharmaceutical teams monitor document status, trace changes, and maintain organized records from authoring and review through approval and archival.