Companies in highly regulated industries are required to develop and use effective monitoring and control systems to ensure product quality and capability of the process through their product development life cycle. PSC Biotech provides experienced staff to ease the process of building a quality system. Our experts have in-depth understanding of ICH Q10, GMP and ISO 9000:2015 and have extensive experience building and implementing such systems for a wide variety of industries.
The consultants at PSC Biotech can help you with all aspects of building or improving your quality system – from writing your quality manual to providing the resources need to implement and/or maintain your systems. We deliver correctly designed and implemented systems to facilitate continuous improvement and ensure that efforts and resources are focused appropriately in proportion to risk. We also assist in structuring management reviews to keep you and your management team always apprised of system information in a concise and expeditious manner. All in accordance to the most up-to-date ICH and ISO 9000 guidelines.
No matter what industry you are in, the experts at PSC Biotech will make sure everything will be in place in order for you to provide the best possible product to your customers.
We offer a full range of Quality Systems services, including:
- Corrective Action and Preventive Action (CAPA) System
- Process Performance and Product Quality Monitoring System
- Change Management System
- Management Review of Process Performance and Product Quality
If you would like more information, get in contact with us directly here.