Autor: stavigent

Stavigent provides audit-ready validation and Quality Assurance (QA) documentation. Using a structured drafting and review process based on GMP, Annex 11, and GAMP 5 principles, documents are created with clarity, consistency, and regulatory compliance, ensuring companies get high-quality deliverables that integrate seamlessly into existing quality systems.

Map. Analyse. Plan. Automate. Monitor. Improve. Repeat. Stavigent identifies manual, error-prone steps in GMP workflows and creates practical automation solutions to significantly reduce human errors.  GAMP-based planning ensures automation solutions follow risk-based validation principles defined in GAMP 5.

Regulatory writing is not creative writing. It is organized, consistent, and rule-driven, making it perfect for controlled AI support. Much of regulatory writing can be automated. Accountability cannot. That’s why AI-supported regulatory writing must be organized, managed, and GMP-compliant. Stavigent enables AI-supported regulatory writing within GMP-aligned frameworks, helping quality and validation teams draft more quickly,…