AI-Supported Regulatory Writing

Stavigent supports AI-assisted regulatory writing within controlled, GMP-compliant frameworks.

Instead of producing uncontrolled content, AI is integrated into structured templates, predefined prompts, and approved document frameworks to support consistent, compliant drafting.

The approach emphasizes speeding up initial drafts, standardizing language, and reducing repetitive manual work, all while maintaining human oversight and regulatory accountability.

By using standardized templates, controlled AI prompts, and review-ready structures, organizations can greatly reduce documentation efforts, enhance consistency across documents, and ensure full compliance with GMP, Annex 11, and GAMP 5 standards.

AI should serve as a drafting assistant, maintaining transparency, traceability, and audit readiness at all times.