Key Services

GxP Audits

Our experienced auditors perform thorough inspections across the full spectrum of Good Practices (GxP), ensuring compliance with global standards and product quality requirements. Connexo's detailed assessments ensure your facility remains inspection-ready, minimizing risk and safeguarding your organization's reputation.

Regulatory Audit Support (GxP Solution Services)

We offer specialized support for audits by major regulatory authorities, including USFDA, MHRA, TGA, ANVISA, MCC, EMA, and other international agencies. Our expertise ensures your organization is prepared, compliant, and capable of effectively navigating these critical inspections.

Computerized System Validation (CSV) Program Development

Our experts design, develop, and implement comprehensive CSV programs, including detailed Master Validation Plans and associated Standard Operating Procedures aligned with the risk-based validation methodologies defined by ISPE's GAMP® 5 guidelines. We establish robust system security policies to safeguard data integrity, ensuring compliance with FDA 21 CFR Part 11 and EU Annex 11. Additionally, we define effective strategies for data backup, restoration, and verification, guaranteeing electronic data is always complete, enduring, and readily accessible. Connexo also develops customized Disaster Recovery Plans tailored specifically to your organization's operational needs. Lastly, our team implements periodic review procedures for validated GxP computerized systems, confirming that systems remain compliant with regulations, continue to meet intended use criteria, and align with your internal processes throughout their entire lifecycle.