Topic-based Authoring: A Content Management Paradigm for Accurate,Consistent Regulatory Documents

Abstract

Regulatory submissions contain quantities of scientifically complex, overlapping, related, and sometimes intentionally redundant content. More often than not, this content appears in various iterations across hundreds, if not thousands, of individual documents. Maintaining accurate, consistent, regulatory-compliant content across so many documents poses an enormous challenge, particularly during the fast pace of a submission. To improve the quality and efficiency of preparation and internal review of regulatory submissions, we explore the potential of a new content management paradigm to provide an authoritative single source of content and to repurpose, track, internally review, and control any content used more than once. We refer to this system as topic-based authoring (TBA).