Module 12 2019

Electronic Document Management Systems

An EDMS (Electronic Document Management System) becomes key for Regulatory Submissions to World-Wide Agencies An optimum document management system makes use of: ● A standardized approach to version control to manage the latest version of all documents

● Approval of documents for inclusion within submissions

● Standard folder structure and metadata for enhanced document storage, search and retrieval

● Rendering technology to automate the creation of document level navigation

● Standardized workflows to streamline the review and approval process

● Metadata capture that can be reused in the submission publishing system

● Standards and processes first prior to system implementation

The Organisation for Professionals in Regulatory Affairs