Risk-based QMS at the core.

Airis operates a fully risk-based Quality Management System designed to deliver high-quality cGLP services and operate in compliance with all applicable regulations. Every dossier is engineered to clear regulator review with minimum cycles.

• Training & analyst qualification
• Good Laboratory Practice (cGLP)
• Instrument · Equipment · Person qualification
• Method development, validation & verification oversight
• Lab environmental monitoring & control
• External audit & finding compliance
• Change control · Incidents · Events · OOS · OOT · CAPA
• Document control · Stability management · Customer complaints