QUALITY SYSTEMS
Quality Management System Support
We can provide advice, coaching and support on understanding current regulatory requirements and expectations. We can review your future plans to ensure they are in line with current and anticipated future requirements. Our expertise brings the deep insights and practical experience needed to help you address the most pressing issues.
FAAUZ Pharma offers the following services but not limited to:
- GAP Assessment of the QMS, e.g., against 21 CFR 211, and ICH Q10
- Data Integrity (DI) Audits and Remediation Plans
- Site Validation Master Plans
- Periodic Reviews
- Change management
- SOPs management
- Deviation management
- CAPA Reviews
- BMR and BPR Reviews
- Calibration and PM Procedures
- Risk Assessments
- Supplier management
Quality System Development
Once it is realized that improvements are needed to any of your quality systems, FAAUZ Pharma can help with development of the most cost-effective and compliant system to meet your company’s needs. We have extensive first-hand experience reviewing systems that did and did not perform effectively, which directly benefits a firm looking to either develop a system from the ground up, or improve their existing system.