Dart Authoring System - For eCTDs, Submissions, Medical Writing - MS Word Single User License
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Yeldell Scientific LLC
D.A.R.T. (Document Authoring & Readiness Tool). The development of the D.A.R.T. began in 2007 after Yeldell Scientific consulted with various technical writers, medical writers, regulatory affairs specialists and dossier managers on the specific needs of authors within highly regulated industries. D.A.R.T. has been continually enhanced since 2007, so it provides over a decade of real-life experience and tools for various use-cases and scenarious involved in content creation and document submission.
The electronic common technical document (eCTD), is now the standard format for the authoring and submission of electronic regulatory documents in the US, Canada, Europe, and Japan. Is your organization ready for eCTD Authoring of Submission-Compliant documents?
The foundation of authoring for eCTD is a system or tool that allows your author to easily create, format and validate regulatory content in a consistently formatted way that adheres to style guides and guidances.
MS Word template-based authoring systems are commonplace in the Biotech, Pharmaceutical, Manufacturing, Medical, and Legal industries due to technical writers, medical writers and quality personnel being tasked with generating regulatory documents (for ex, clinical protocols, lab reports, CTDs, standard operating procedures, package inserts, leaflets, medical study reports, legal decisionals) that must be submitted to worldwide health authorities (FDA, EPA, EU, MHLW, OECD, etc.) according to stringent submission-ready authoring standards rooted in ICH guidance. Compliant, consistent, high-quality regulatory documents facilitate review processes, enable regulatory submissions and ultimately lead to a smooth pipeline allowing industries to get their product approved for use on the market or communications disseminated faster.
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Our D.A.R.T. authoring system fosters submission-ready authoring by enabling authors of any skill level with easy to use “point-and-click” tools via a custom Microsoft Office Ribbon Interface that allows for a harmonized look and feel across all produced documentation by enforcing standards with respect to:
Fonts, Heading Styles and Spacing
Margins, Paper Sizing and Orientation
Tables and Figures
Referencing and links
Footnotes and Endnotes
Insertion of Symbols and Units of Measures
Lists (Table of Contents, List of Tables, List of Figures)
DART (Document Authoring & Readiness Tool)
The DART authoring system gives your medical and technical writers a familiar interface and experience of MS Word, while providing a compilation of functions, tools, restrictions and utilities that conform to best authoring practices, regulatory authority guidelines and formatting standards via a custom, integrated Microsoft Office Ribbon.
The DART Ribbon extends to provide an author with important authoring functions.
With DART, styles, tables and cross references are made easy!
DART fosters reusability, search-ability, structured authoring and single sourcing by leveraging use of metadata with respect to:
Custom Properties and Specific Bits of Metadata can be stored and leveraged for insertion into documents and downstream applications, content mgt systems and rendering engines.
Example: Using DART and MS Word to Create Structures, Assemblies of Documents, eCTD via MS Word Ribbon
All thats required is a Windows Laptop/PC and MS Word 2013 or higher.
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