Section Editors: Clare Chang, Zuo Yen Lee

Article Title: Improving consistency and reducing structural risk in regulatory writing through rule-based automation: A practical example using a Microsoft Word add-in
Author: Eszter Székely
Abstract: Regulatory documents are complex, highly structured, and subject to strict compliance requirements. While scientific accuracy remains central, non-scientific issues such as formatting inconsistencies, broken cross-references, and template deviations can significantly affect document quality and review efficiency. As document volumes increase and regulatory requirements continue to evolve, manual quality control becomes difficult to scale and is prone to late detection of issues. This article examines key operational challenges in regulatory writing and discusses how rule-based and hybrid validation approaches can support consistency and reduce structural risk. Rather than generating content, these systems apply deterministic checks and hybrid validation to ensure alignment with templates and document logic. Using a representative Word add-in as an example, the article illustrates how rule-based and hybrid validation can be integrated into drafting workflows. When properly governed, such approaches can improve repeatability, reduce rework, and support more efficient regulatory document preparation without replacing expert oversight.