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
Made with FlippingBook - Online catalogs