seQure 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 created a network of experts with over 25 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 the customer’s needs.
Services and Consultancy for Quality Management and Assurance:
- 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
- Qualified person (GMP)
- FSP QA GxP
- Inspection readiness
- Remediation Plans
- 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
- QP Services for manufacturing Plants (CMOs)