What
is CADDY? CADDY is a concept that provides all necessary
information and tools for industry to allow preparation
of "CADDY-conform" electronic dossiers, and for
regulatory authorities to review these dossiers.
CADDY itself is the acronym for Computer
Aided Dossier and
Data Supply.
CADDY-xml is based on the legacy CADDY 2.0
format, but introduces some important differences by
providing the general information, a table of contents,
confidential and non-confidential documents, report
information and hyperlink information in an
xml
framework. The CADDY-xml Converter can be used to
convert legacy CADDY 2.0 dossiers to the new standard
CADDY-xml.
CADDY 2.0's TIFF-files are replaced by
PDF/A versions of the documents, which can be either
image-based or text-based. Additionally, a CADDY-xml
based dossier can be instantly viewed with a common
web-browser supported by Acrobat Reader. This standard
is flexible to accommodate different dossier structures or standard Table of Contents such as OECD, EU or others.
Within this setup the XML-representation can be thought of as the backbone of
the dossier. It references every document
PDF that is included within the
table of contents and provides
additional attributes for the dossier and each document.