Product: EMC Documentum Submissions Manager for eCTD

Documentum Submissions Manager for eCTD
Content submissions management for life sciences organizations

EMC Documentum Submissions Manager for eCTD helps to create, manage, assemble, track, and deliver controlled content submissions to government regulatory agencies. Submissions Manager for eCTD supports the regulatory submissions process for electronic common technical documents (eCTDs) as defined by the International Conference on Harmonization (ICH) for the exchange of data between pharmaceutical companies and regulatory agencies.

In addition, Submissions Manager for eCTD supports U.S. eCTD schemas out-of-the-box and can customize support schemas for Europe and Japan.

Descriptive & Technical Info

Solution Brief

View all related assets

EMC Documentum Submissions Manager for eCTD delivers:

Features	Benefits
eCTD lifecycle management	Enable the creation, building, and publishing of eCTD submissions and deliver full life-cycle support for submissions like rolling submissions when you use Submissions Manager for eCTD.
Compliant templates	Meet ICH guidance including table of contents headings and hierarchy, module 1 for administrative information, and prescribing information.
Automatic submission	Automatically generate an eCTD backbone so submissions can be automatically validated against the eCTD specification and a checksum created.
Study Tagging File (STF) specification support	Facilitate capture of STF attributes through easy-to-use forms along with clinical study group information. Submission assembly – Leverage drag-and-drop, web-based virtual document/assembly support.
Submission assembly	Leverage drag-and-drop, web-based virtual document/assembly support.
Adobe PDF and Microsoft Office support	Support Portable Document Format (PDF) hypertext linking for creation and review as well as PDF rendering from Microsoft Office, including bookmark and hyperlink support.
Complete workflow	Enable review and approval, locking and unlocking of submissions, and reuse of documents across submissions.
Regulated content	Include in submissions regulated content that has been created and is being managed through EMC Documentum Compliance Manager.

Available Evaluation Software.

Product Name	Operating Environment

Documentum Advanced Document Transformation Services -Documentum Advanced Document Transformation Services enhances your documents and supports the electronic common technical document (eCTD) specification submission process with advanced rendering features.

Documentum Trusted Content Services -Activate advanced content security controls with specialized encryption, and access control and disposal features to meet your most security-sensitive needs.

phone 03-645-4222