banner
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

EMC Documentum Submissions Manager for eCTD delivers:

FeaturesBenefits
eCTD lifecycle managementEnable 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 templatesMeet ICH guidance including table of contents headings and hierarchy, module 1 for administrative information, and prescribing information.
Automatic submissionAutomatically generate an eCTD backbone so submissions can be automatically validated against the eCTD specification and a checksum created.
Study Tagging File (STF) specification supportFacilitate 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 assemblyLeverage drag-and-drop, web-based virtual document/assembly support.
Adobe PDF and Microsoft Office supportSupport Portable Document Format (PDF) hypertext linking for creation and review as well as PDF rendering from Microsoft Office, including bookmark and hyperlink support.
Complete workflowEnable review and approval, locking and unlocking of submissions, and reuse of documents across submissions.
Regulated contentInclude in submissions regulated content that has been created and is being managed through EMC Documentum Compliance Manager.

Available Evaluation Software.


Product NameOperating Environment
Authoring Integration Services -EMC Documentum Authoring Integration Services enables users to easily access the EMC Documentum repository from the desktop or from within certified applications.
Notes: