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GECCO - the Leading eCTD Viewer/Validator

Announcing GECCO Version 1.4.1

EU Module 1 Version 1.4 Support

Enhanced validation rules including complete "as published" rule sets for EU and CA

EU Module 1 Version 1.4

GECCO now is fully compliant with the new EU Module 1 specification version 1.4 (http://esubmission.emea.europa.eu/eumodule1/index.htm). A number of validation rules have been added to support the new "submission mode" attribute. A new rule for checking that path length is 180 or less in accordance with the EU guidance has been added. GECCO now supports versions 1.0, 1.1, 1.2.1, 1.3 and 1.4 of the EU regional DTD.

EU eCTD Validation Criteria (version 2.1)

The complete published set of validation criteria for the EU is now supported. See http://esubmission.emea.europa.eu/ectd/index.html

CA eCTD Validation Rules (dated November 13, 2007)

The complete published set of validation rules for Canada is now supported. See http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/ectd_validation-eng.pdf

DTD Validation

GECCO's method of validating XML vs. the DTDs has been strengthened. If a non-published DTD is found (checksum does not match the published checksum) GECCO's internal copy of the correct DTD is used to parse the XML instance.

GECCO provides a uniform and consistent view of eCTDs in the different regions. It is a compact program (< 3 MB) which runs on Windows 2000 to Windows Vista. There is no server component - eCTD folders and files simply need to be accessible to the user's PC.

GECCO quickly loads all sequences of an eCTD, running over 150 rules to confirm compliance. The viewer then displays the current view or STF view, showing the "table of contents" (eCTD backbone) in a left hand panel and allowing quick and convenient navigation to any location or document in the eCTD. The STF view applies the study and file tags and renders a convenient study report view.

To get GECCO, simply register on this site, log in and click "Get GECCO". A 30 day free trial is provided. License keys may be purchased on line by clicking "Get GECCO" and then "Purchase License Key(s)".