IQ OQ PQ Qualification
Equipment IQ OQ PQ Qualification and Process Validation Services
Metcal has offered IQ OQ PQ Validation Services to the biopharmaceutical and medical industry since 1996. We specialize in executing large-scale qualification projects including autoclaves, chambers, freezers, retorts, stabilities and warehouses. Our goal is to build long-term relationship with customers to support them throughout. Validation Software used by Metcal that are 100% compliant with FDA 21 CFR Part 11 and GAMP5 regulations.
Services Provided
Project Planning Management
Risk and GAP Analysis
IQ OQ PQ Protocol Development, Site Execution and Final Summary Report
Regulatory Compliance Assessments
Deviation Reporting and Follow Up Actions, Improvement and Preventive
IQ OQ PQ Validation Awareness Training
Ensuring Performance and Meeting Regulatory Requirements
- Installation Qualification (IQ) is to verify that all the key aspects of the design, procurement, and installation are reported
- Operational Qualification (OQ) is to verify that the system performs as intended at all anticipated operating ranges
- Performance Qualification (PQ) is to verify that the process does what it is intended to do, in the correct anticipated manner
- Continuous Qualification (CQ) / Re-Qualification (RQ) is to verify that the process is still performing to the standards necessary
Quality Assurance
Our team will review your validation reports, ensuring your validation reports received in utmost confidence with no errors.
- Executed Protocols or SOPs
- Hard and Soft Copies of Raw Data
- Validation Personnel Training and Experience Records
- Pre/Post Calibration Report of Validators and Data Loggers Used
Kaye Validator V.S MadgeTech Wireless Data Logger
Metcal can provide the right validator, wireless data logger to ensure your IQ OQ PQ activity in compliance throughout the entire validation process. Identifying cold and hot spots to real-time reporting and alarm notifications you will have control of your process and quality of goods 24/7. Logging all levels of temperature, relative humidity, dew point, pressure and carbon dioxide (CO2).
