eDOCSmanager Regulatory - A Secure Document Management System for Life Sciences
Are you dealing with an increasing documentation backlog?
- I am overwhelmed by the number of places where documents are stored
- I am never completely sure where to find the documents I am looking for
- I am worried about sending an outdated version of a document to the agency
- We lack the processes, expertise, and infrastructure to scale-up
- I am concerned about working with potentially outdated documents
- We are worried about delays because our documents are not ready in time
- I am fed up with searching countless submissions for the document I need
- The day doesn’t have enough hours to complete my regular tasks
A secure document management system for regulatory submissions
The EXTEDOpulse Regulatory DMS provides a platform for managing submission documentation in a controlled and automated manner; enabling you to focus on creating your submission content rather than managing it.
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Efficient document generation
Use industry best practices to achieve consistent, efficient regulatory results. The eDOCSmanager Regulatory Module ensures that your submission documents are accurate and organized. The submission content planning functionality allows transparent and detailed preparation and conception of regulatory documents in the DMS directly. Share content between different markets for more efficient regulatory document generation. Digitally collaborate to build customized structures and assign content as needed with drag & drop functionality or prebuilt templates. Finally, transfer your documents into a variety of formats, including zip, Word, or PDF.
Consistent regulatory data with EXTEDOpulse
EXTEDOpulse provides a shared master data management and controlled vocabulary layer across the EXTEDOpulse hubs, including the Document Management Hub. Product and regulatory attributes are reused when creating and managing documents, ensuring consistent metadata and terminology across dossiers, submissions, and change processes. This reduces manual effort, minimizes errors, and establishes a single source of truth for regulatory information across the solution.
Seamless integration for efficient submission management with EXTEDOpulse
eDOCSmanager Regulatory, together with the Submission Management Hub, streamlines submission content planning, document management, and submission execution across the submission lifecycle. Submission content plans within eDOCSmanager Regulatory, enable teams to define required documents, responsibilities, timelines, and progress directly within the document management solution. Content plans originating from or maintained in eDOCSmanager Regulatory can be seamlessly transferred into the submission structure within the EXTEDOpulse Submission Publishing solution to support automated compilation and synchronization of documents and versions. Exported submissions are automatically uploaded to the submission archive and made available in the EXTEDOpulse Submission Viewing solution. During this process, links between archived documents and their original sources are created automatically, while the “Where Used” functionality provides transparency into document usage across submissions, preserving relationships and improving traceability and compliance.
Services
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Business Process and Regulatory Consulting Services
Tailored specifically to the needs of regulatory and related stakeholders, EXTEDO’s business process and regulatory consulting services are designed to support you during and after your eCTD submissions. Through a series of workshops, our team of experienced consultants will establish your business needs, understand your processes, and help you to define the most appropriate implementation approach.
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Education & Training Services
To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOpulse solution portfolio. Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics. Designed to educate you on how to utilize your EXTEDO solution, our training sessions are conducted either in-house or onsite.
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Technical Consulting
Purchasing a new EXTEDO application is the first step to streamlining business and regulatory processes within your organization. However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution.
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Validation Services
Successfully passing an audit from the regulatory agencies requires validated computerized systems. Our team of validation experts has an in-depth knowledge of life sciences business processes, ensuring a tried-and-tested method of system validation. By utilizing the risk-based approach to compliant GxP computerized systems defined within the GAMP 5 standard, we aim to reduce the time, effort, and cost associated with getting your systems up and running.
