skip to main content

OpenText Documentum Submission Store and View

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

Learn about OpenText™ Life Sciences solutions to effectively manage regulatory submission documentation and address regulatory challenges
Documentum Submission Store and View

What is electronic submissions and regulatory correspondence management for Life Sciences

Compliance and security are compromised when records are scattered across a variety of repositories, laptops, collaboration spaces and shared drives. Related communications, such as emails, meeting minutes and phone records, can also present tracking challenges. Electronic submissions and regulatory correspondence management keeps current, complete records of all documents and communications associated with the drug applications submitted to regulatory agencies, both directly and through affiliates.

OpenText Documentum Submission Store and View overview

Simplify the search and retrieval of archived submissions and their associated correspondence, while improving security and compliance with OpenText™ Documentum™ Submission Store and View. Part of OpenText Documentum for Life Sciences solution, Documentum Submission Store and View links regulatory correspondence and communications to submission files for a full view of regulatory activities.

OpenText Documentum Submission Store and View features

  • Find everything in one place

    Easily retrieve the regulatory correspondence associated with applications and submissions with a 360-degree view of regulatory activities.

  • Secure repository for published output

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

  • Streamlined viewing

    Provides standard eCTD views, single, current and cumulative, of the full regulatory application lifecycle, including navigation of hyperlinks. Standard cabinet-folder hierarchy allows navigation and views of the NeeS or paper submission.

  • Connect source and published output files

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

  • Email integration

    Drag and drop emails with attachments from Microsoft® Outlook® to create a single record for the respective communication.

Benefits of OpenText Documentum Submission Store and View

  • Enhance submission visibility

    Get a complete view of regulatory activities within application displaying submission and correspondence records in a single view.

  • Improve time to market

    Ensure efficient and transparent tracking of open/closed queries and speed responses to health authorities.

  • Ensure compliance

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

  • Control security

    Further strengthen compliance by setting access control, password strength and log-in attempts to ensure appropriate access to content.

Contact us to speak with a member of the Life Sciences team