Quality
Gsap establishes a culture for quality and improves the quality system management (QMS). We develop together with the client a comprehensive quality system to suit the organization and the product, for clinical care and commercial applications.
Our quality experts in Gsap, can help you establish these matrices, properly collect the data, analyze the results and set actions for improvement. These effective implementation principles are followed: (i) Manage the Metrics, ((ii) Interpret in context, and (iii) Apply internally.
Risk management
According to applicable standards such as ISO 14971 ,including dFMEA & pFMEA
Design & development controls
Including design reviews and planning of product realization
Product Verification and Validation (V&V)
Support writing and review of protocols and reports
Purchasing controls and acceptance
Sampling inspection according to international standards and applicable statistical guidelines
Transfer to production
Quality planning and execution of transfer to production and Process Capability analysis
Process Verification and Validation
Including IQ/OQ/PQ/TMV
Quality improvement
Non-conforming product (NC), Complaint handling, Corrective and Preventive Action (CAPA)
