Follow
User Requirement Specificatio (URS):
Define the intended use of the instrument.
List performance requirements, such as accuracy, precision, and operational range.
Include compliance needs with GMP, GDP, or other regulatory guidelines.
Design Qualification (DQ):
Document that the design of the instrument meets the URS and regulatory requirements.
Assess vendor qualifications and technical specifications of the instrument.
Risk Assessment:
Identify potential risks related to instrument failure or deviation.
Implement controls to mitigate risks.
Installation Qualification (IQ):
Verify that the instrument is installed correctly according to the manufacturer’s recommendations.
Document all components, utilities, and environmental conditions.
Ensure proper connections, calibration, and software setup.
Operational Qualification (OQ):
Test the instrument’s performance under operational conditions.
Validate key parameters, such as temperature, pressure, or flow rate, as applicable.
Ensure it operates consistently within the specified limits.
Performance Qualification (PQ):
Demonstrate that the instrument performs reliably under real-world conditions.
Conduct tests using actual samples or processes.
Confirm reproducibility, precision, and accuracy.
Documentation:
Maintain detailed records of all qualification activities.
Include certificates, test results, protocols, and deviations (if any).
Training:
Train personnel on the proper use and maintenance of the instrument.
Document training records.
Routine Calibration and Maintenance:
Establish a schedule for regular calibration and preventive maintenance.
Monitor instrument performance and address any issues promptly.
