Documentum for Life Sciences

OpenText Documentum Submission Store and View

Get a 360-degree view of regulatory activity and improve archived submissions compliance

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Overview

Track archived submissions and associated health authority correspondence

OpenText™ Documentum™ Submission Store and View, part of OpenText™ Documentum™ for Life Sciences, simplifies the search and retrieval of archived submissions and their associated correspondence, while improving security and compliance.

Why choose OpenText Documentum Submission Store and View?

  • Flexible deployment

    Leverage cloud-native software that offers the choice to deploy on-premises, in a hybrid environment or in the cloud.

  • eCTD and NeeS support

    Import eCTD and NeeS submissions using a single regulatory application registration form, saving time and ensuring compliance with health authority guidelines.

  • Easy upgrades

    Leverage containerized architecture to easily upgrade and access new features, capabilities and updates.

  • Single source of regulated content

    Eliminate the need to import and export across systems with one enterprise-wide content source that includes multiple solution modules for cross-domain searches and linking.

How Documentum Submission Store and View can benefit business

Discover the advantages of using Documentum Submission Store and View.

Read the overview

  • Accelerate time to market

    Reduce the response time for regulatory and health authority requests through efficient and transparent tracking of open/closed queries.

  • Improve submission visibility

    Achieve a 360-degree view of regulatory activities and submissions with all correspondence and records available in a single view.

  • Manage grouped submissions

    Automatically link primary applications to secondary applications or sequences to improve accuracy and reduce the number of manual processes.

  • Ensure compliance

    Move submission files off uncontrolled file shares into a secure, compliant repository.

Features

  • Simple content visibility

    Retrieves all correspondence associated with regulatory applications and submissions, while ensuring a 360-degree view of regulatory activities.

  • Streamlined viewing

    Offers industry-standard eCTD views of the entire regulatory application lifecycle, including single, current and cumulative views, and navigation of hyperlinks. Allows users to navigate and view NeeS or paper submissions using a standard cabinet-folder hierarchy.

  • Email integration

    Creates a single communication record using capabilities to drag and drop emails with attachments from Microsoft® Outlook®.

  • Secure repository for published output

    Tracks submissions and associated correspondence with audit trails and indexing for clarity and increased visibility into communications with regulatory agencies.

  • Connected source and published output files

    Links source documents to the respective published output file for complete traceability from authoring to submission.

Take advantage of OpenText and partner services

Deployment

OpenText offers deployment choice and flexibility for Documentum Submission Store and View.

Professional Services

OpenText Consulting Services combines end-to-end solution implementation with comprehensive technology services to help improve systems.

Partners

OpenText helps customers find the right solution, the right support and the right outcome.

Training

OpenText Learning Services offers comprehensive enablement and learning programs to accelerate knowledge and skills.

Communities

Explore our OpenText communities. Connect with individuals and companies to get insight and support. Get involved in the discussion.

Documentum Submission Store and View resources

Gaining a complete view of regulatory activity

Read the position paper

Track archived submissions and associated health authority correspondence

Watch the video

What’s new in OpenText Life Sciences solutions

Read the blog

Are you ready for IDMP 2.x?

Read the blog

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