We verify not only that the system works, but that it does so consistently and in compliance with regulatory requirements.
What we deliver
We carry out commissioning and validation of Life Science facilities, ensuring that each system operates according to defined specifications and meets GMP requirements.
We verify the actual performance of the installation and document its operation to ensure suitability for production use.
A proper validation allows →
- Ensure GMP compliance
- Verify actual system performance
- Reduce production risks
- Facilitate audits and inspections
- Ensure full traceability of the installation
Value →
A system may be correctly installed, but it is not operational until it is demonstrated to perform within defined parameters.
Validation is the process that ensures the facility meets regulatory requirements and can operate reliably.
Up to 30% fewer validation deviations through proper system preparation and control
We develop structured qualification processes in line with GMP guidelines to verify that the installation meets defined requirements and is suitable for production use.
01.
Installation Qualification (IQ)
We verify that all systems have been installed in accordance with design, technical specifications and project documentation.
Includes:
• component and equipment review
• installation verification
• technical documentation check
02.
Operational Qualification (OQ)
We verify that systems operate correctly within defined operational parameters.
During this phase:
• operating conditions are tested
• temperature, humidity and pressure ranges are verified
• HVAC systems and utilities behaviour is checked
• alarms, controls and automation systems are validated
03.
Performance Qualification (PQ)
We validate system performance under real operating conditions.
This phase confirms that:
• the system maintains stability over time
• environmental conditions remain within defined limits
• the process can be performed consistently
PQ is directly linked to production activity, ensuring that the installation is suitable for its intended use.
