7 Dec, 2009 – S-Cubed is a leading electronic regulatory submission solution that conforms to the current International Conference on Harmonization (ICH) and regional requirements for delivering eCTD
and NeeS submissions to the USA, Europe, Canada, Japan, and Taiwan regulatory agencies.
This latest version of S-Cubed now supports the EU eCTD Module 1 v1.4. Sponsor companies
are advised that as of January 1, 2010 when the new mandate comes into force, the EU eCTD
Module 1 v1.4 must be used for all eCTD submissions for all European procedures. Any eCTD
submissions provided from this date using any previous version of the EU Module 1
specification (v1.0. v1.1, v1.2.1 or v1.3) will not be accepted.

“The Datafarm development team has been working on the enhanced compliance feature since
the EMEA released Version 1.4 of the EU Module 1 Specification in August of 2009,” said Shy
Kumar, CEO at Datafarm. “S-Cubed users can rest assured that version 4.3 ensures
compliance with the latest EU specification.”

In addition to the updated compliance requirements, Datafarm delivers integration with
OpenText ECM to enable users a seamless link to S-Cubed from the content management
system. This integration resulted from user and prospect requests and joins the ranks of
leading content management integrations S-Cubed currently offers including EMC
Documentum, Microsoft SharePoint, NextDocs, MaterControl and Qumas.

For more information on S-Cubed click here.