Audit & Remediation
Connexo's Audit & Remediation services offer comprehensive and targeted inspections designed to thoroughly assess your facility's compliance status, operational effectiveness, and readiness for regulatory scrutiny. Our expert team assists in identifying and addressing potential compliance issues promptly and efficiently.
Key Services
GxP Audits
Our experienced auditors assess GxP processes against applicable standards and product quality requirements. The findings help teams identify gaps, prioritize remediation, and prepare for inspections.
Regulatory Audit Support (GxP Solution Services)
We offer specialized support for audits by major regulatory authorities, including USFDA, MHRA, TGA, ANVISA, SAHPRA, EMA, and other international agencies. We help your organization prepare evidence, address compliance gaps, and respond effectively during these inspections.
Computerized System Validation (CSV) Program Development
Our experts design, develop, and implement comprehensive CSV programs covering:
Validation Plans and SOPs
Detailed Master Validation Plans and associated Standard Operating Procedures aligned with the risk-based validation methodologies defined by ISPE’s GAMP® 5 guidelines.
System Security
We establish system security policies and controls that support data integrity and applicable FDA 21 CFR Part 11 and EU Annex 11 requirements.
Backup, Restoration, and Verification
We define backup, restoration, and verification strategies to help preserve complete, retrievable electronic records throughout their required retention period.
Disaster Recovery
Connexo also develops customized Disaster Recovery Plans tailored specifically to your organization's operational needs.
Periodic Reviews
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.