AgRay offers advanced solutions for Quality and Compliance in all GxP areas, supporting individual client needs in finding the most effective system to meet regulatory requirements, reach their goals and improve processes.
We have established a network of experts with over 20 years of experience in: Implementation of Quality Management Systems, Support for GxP audits and Computer System Validation. In addition, our team offers training courses on Quality Assurance & Compliance.
Each QMS plan is defined and created based on QM policies, processes and procedures of the QMS in compliance with the ISO 9001:2000.
We ensure that final quality managemnt solution meet the following standards:
- Comprehensive and detailed design
- implementable in target site
- extensively documented
- effective monitoring and control mechanism
Quality Assurance Management Support
- Quality Management Services: from process assessment to implementation, analysis and system improvement
- Standard Operating Procedures (SOPs), Policies: creating documents and tools to improve readability and compliance
- GxP Audits: from defining client processes to planning, conducting and reporting
- Quality and compliance for pharmacovigilance: from system assessment to third party audits
- Training: analysis and assessment of training needs
- GxP Inspections: from assessment of compliance status, gaps and needs to supporting clients in the preparation and management of inspections
- System and Database Audits, Software House Audits, Suppliers and Service Providers
- On site and off site GMP mock audit based on EU standards
- Clinical trial designs & project management
- Scientific advice and health authority meetings
- Bio-equevalent studies
- Due diligences