Resource CQV is your partner in quality control and compliance consulting
Commissioning, Qualification & Validation
Resource CQV is your partner in quality control and compliance consulting
Resource CQV is your partner in quality control and compliance consulting
Resource CQV is your partner in quality control and compliance consulting
Commissioning ensures that equipment and facilities are installed and operating according to design specifications. This process focuses on verifying functionality, safety, and compliance during the early stages of project implementation. It sets the foundation for smooth startup and seamless transition to qualification.
Qualification is the documented process of proving that systems and equipment perform as intended consistently and reproducibly. It is broken into stages: Installation Qualification (IQ), Operational Qualification (OQ), and sometimes Performance Qualification (PQ). This step is critical for compliance with GMP (Good Manufacturing Practice) regulations.
Validation provides documented evidence that a process, method, or system produces consistent, compliant results. This extends beyond equipment to include manufacturing processes, cleaning methods, software systems, and analytical procedures. Validation is essential for ensuring product quality, safety, and regulatory compliance.
Performing and documenting tests to confirm that equipment or systems have been installed correctly and meet all predefined design and installation requirements. Proper execution ensures the system is ready for further qualification (OQ) and supports compliance with GMP and regulatory standards.
Testing and documenting that equipment or systems operate as intended across all specified ranges and conditions. OQ confirms that the system performs reliably and consistently, forming a key step in demonstrating compliance with regulatory standards.
Verifying that the entire space remains within specified limits under normal and stress conditions, temperature mapping helps prevent product degradation, ensures consistency across storage zones, and supports compliance with GMP and regulatory guidelines
Verifying that computerized systems—such as Laboratory Information Management Systems (LIMS), Manufacturing Execution Systems (MES), or electronic batch records—perform reliably, accurately, and in compliance with regulatory requirements.
CSV ensures that data integrity, traceability, and security are maintained.
Proving that a cleaning procedure consistently removes product residues, contaminants, and cleaning agents to predefined, acceptable levels. It ensures that manufacturing equipment and surfaces do not introduce cross-contamination or compromise product quality
Verify that High-Efficiency Particulate Air (HEPA) filters are installed correctly and are functioning as intended, without leaks or defects. These filters are essential in cleanrooms and controlled environments to maintain air quality by trapping airborne particles, microbes, and contaminants.
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