Process Validation
Having years of experience, our highly experienced team understands the concerns companies face in this highly regulated environment. The first step in process validation in manufacturing is to identify the risks and critical control points of the process. Which aspects of the process will impact product quality i.e. GMP risk, if they fail, or if they fall outside the control parameters?
QABASA has years of experience in delivering successful solutions. We can help with the following activities and deliverables.
- Quality Systems Regulation and Standards for medical devices and process validation
- Design Control and Risk Management
- Process validation prerequisites including validated test methods
- statistics and quality metrics calculations
- Verification versus Validation
- Validation Master Plans
- Process development / Engineering studies and Design Controls
- Design of Experiments (DOE)
- Installation qualification (IQ)
- Automated Processes and Software validation
- Operational qualification (OQ)
- Performance qualification (PQ)
- Validating manual processes
- Establishing methods for cleaning, facilities, utilities, and sterilization
- Validation Process Failure Mode and Effects Analysis (PFMEA)
- Process Monitoring and Control
- Revalidation
- Documentation for process validation