Equipment and Facility Qualification:
Ensure Functionality and Regulatory Compliance
Why is equipment and facility qualification essential?
In sectors such as pharmaceuticals, biotechnology, and healthcare, ensuring the proper functioning of equipment and facilities is crucial for quality, safety, and regulatory compliance. Qualification confirms that each system operates according to standards such as GMP (Good Manufacturing Practices) and ISO 17025.
Benefits of our qualification service
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Guaranteed regulatory compliance
We align with GMP, FDA, and EMA standards to ensure your equipment meets all requirements.
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Performance optimization
Qualification helps identify deviations and improve operational efficiency.
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Reduced risk of failures
Minimizes production errors and ensures process quality.
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Expert technical support
Our team assists with deviation resolution and continuous improvement of your facilities.
Ensure the proper functioning of your equipment and facilities with our qualification service. Comply with regulations and optimize operational performance.
Our equipment and facility qualification service
We have a specialized team responsible for qualifying a wide range of equipment types, ensuring validation and optimal performance. The equipment we qualify includes:
- Particle counters
Critical for environmental monitoring in cleanrooms and production areas. - HVAC systems
Ensure proper ventilation and air filtration in controlled environments. - Thermal equipment
Includes autoclaves, ovens, and climatic chambers that require temperature validation and thermal uniformity. - CIP/SIP cleaning systems
Essential for decontamination processes in pharmaceutical manufacturing. - Production equipment
Verification of machinery used in drug, biotech, and medical device manufacturing. - Analytical instruments
Ensure the accuracy of laboratory measurement and analysis equipment.
