Electronic Common Technical Document

The specifications for creating the eCTD Backbone Files and Study Tagging Files (techncal documents that follow the eCTD Specifications).

U.S. Federal Drug Administration (2006). Resources>Documentation>Standards

Defining Quality for Documentation Practices

Defining quality means developing expectations or standards of quality. Standards can be developed for inputs, processes, or outcomes; they can be clinical or administrative. Unfortunately when it comes to documentation, many companies only focus on the standards related to time and accuracy. Quality standards should be in place for all aspect of the documentation development pathway—moving from planning, to authoring, to reviewing.

Cuppan, Gregory. Brainery.net (2009). Resources>Business Communication>Documentation>Standards