eCTD 247 Enterprise Offer

eCTD submission

eCTD templates Submission templates that conform to ICH eCTD standards are also provided for:

• Modules 2-5
• Module 1 for Europe, Switzerland, the United States, Canada and GCC

 

Submission dossier compilation Adding documents to your submission is as easy:

• Drag and drop documents from the EDMS interface to the eCTD dossier interface
• Documents will always be up to date in your dossier should a new document version be created

 

STF file management

• You can generate your STF file (Study Tagging File) for publishing your eCTD application to the FDA.

 

eCTD ValidatorThe eCTD Validator operates before and after publication:

• The validation reports any non-conforming element of the dossier (incorrect filename, missing elements, too large files, etc)
• Direct access to the incorrect items
• The user can edit before making the publication

 

Generation of the publicationFrom a template, you can publish a complete dossier or a part of that dossier, which will be included in the complete dossier. You can also duplicate a dossier for submission to a new region. The dossier generates all the necessary elements for you:

• The folder trees
• The XML Backbone files: envelope and regional, STF file

 

Submission dossier life-cyclee-CTD sequences enable management of the dossier life cycle. You can view:

• a consolidated version of the dossier (the set of all sequences that have occurred)
• a differential release (additions, modifications or deletions of the current sequence).

 

Submission managementSubmissions are a special type of document and benefit natively from:

• Automatic calculation of references
• Management of the approval cycle (configurable for each file type)
• Automatic recipient notification (configurable by e-mail)
• Version management
• Storage, archiving of documents

 

Electronic publication visualization

• It is possible to generate a draft eCTD, NeeS or vNeeS publication. The draft for example enables validation during the composition of the dossier to ensure the hyperlinks based navigation is correct.

 

Publication management

• The result of the eCTD, NeeS or vNeeS publication of a dossier is stored in the Document Management System. Any publication submitted to an agency is preserved identically and securely. You can view it without extracting the publication on a file server. It is also possible to archive your files for long-term preservation.

 

Hyperlink managementAn advanced hyperlink management function is provided:

• The links of all PDF documents of a dossier are analyzed and invalid links are reported.
• You can change these links to make them valid
• You can insert “submission-level” links

 

Document management

 

eCTD 247 Premium comes with Ennov Doc EDM (Enterprise Document Management) solution integrated. You can drag and drop your documents from the EDM to the submission management interface.

 

Documents templates

• The EDMS enables use of document templates for all required document types.

 

DIA EDM reference modelThe DIA EDM reference model is an industry standard that will save you time and lower risk configuring your application.

• eCTD247 Premium is pre-configured according to the DIA EDM Reference Model
• You can change this configuration
• You can build an entirely new configuration

 

Metadata basedEnnov’s EDMS is metadata based. That means your documents will always be quick and easy to retrieve:

• The powerful search engine uses both document contents and metadata to search for the document
• Configurable views enable to browse the document database according to any metadata combination

 

Common capabilities

Collaborative work

• Several authors can work together on the same document or the same submission. A check-in/check-out mechanism allows to coordinate their modifications.

 

21CFR Part 11 traceability and electronic signature

• eCTD 247 Premium is fully compliant with 21CFR Part 11 requirements of the FDA.

 

Other publication formats

• eCTD 247 also enables to publish in NeeS or vNeeS (for veterinary customers).