Submission Document Authoring

Submission Document Authoring can be a complex process that impacts multiple functions throughout the organization. Standardization throughout the process is the key to success. Octagon offers multiple products that facilitate the document authoring process. Standards apply to:

1. Storage of documents
2. Content and format of documents
3. Organizational interpretation of agency guidances

Storage of Documents
eCTD JumpStart™ provides standards for file naming conventions and folder structures within the authoring environment. This enables authors to work efficiently and access content in a consistent manner across the organization.

Content and Format of Documents
StartingPoint^® is a collection of submission document authoring templates that have been developed based on industry guidances and best practices. These predefined templates support eCTD authoring and provide a consistent look and feel to submission documents being created around the globe.

Organizational Interpretation of Agency Guidances
The Global eCTD Guidance Interpretation synthesizes over 30 different agency guidances and provides a common understanding and interpretation of these documents in one concise, user-friendly document.

All of these solutions can be implemented on a file share or within the ViewPoint^® process management platform. ViewPoint^® for Document Management provide a secure environment where users can automate authoring processes, enforce standards and manage processes more efficiently.

If you need help defining or refining authoring processes or implementing standards, get help from our Process Consulting team.