Tuesday, August 12, 2008

ECTD - Electronic Common Technical Document

Based on the Common Technical Document the ECTD (Electronic Common Technical Document) is a protocol for regulatory submissions for the pharmaceutical industry to government health agencies such as the US FDA (Federal Drug Administration) or the EMEA (European Medicines Agency).

These agencies require a specific protocol for document submission including metadata that can be easily transferred from one party to another. The general requirement includes a main directory folder, an XML file that includes metadata on the document, and sub-folder organization with stylesheets that provide formatting information.

The latter provides elements such as hyperlinks, headers, footers, etc. Document Type Definitions (DTD) are also required. DTD is a syntax methodology that defines the document structure (it's class or type).

The effective implementation of ECTD to meet government submission guidelines can be streamlined by improving the source documents and conversion process. Initial document conversion, OCR, formatting and inclusion of hyperlinks improves the efficiency of the process.

Adlib ExpressEnterprise Server produces mission critical PDF's that provide the necessary components for meeting regulatory submission guidelines. This includes the ability to augment, reorganize and (re)format PDF's using an automated process.

For more information on Adlib Software solutions, visit our website.

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