Regulatory-compliant qualification of systems and equipment

Safe and stable manufacturing processes can only be guaranteed if systems, equipment and rooms demonstrably comply with regulatory requirements. Qualification creates the basis for process reliability, product quality and audit readiness - whether for new plants, conversions or regular requalification.

Our qualification services
EXCO offers comprehensive services for the qualification of production systems, cleanrooms and equipment:

• Commissioning: Structured commissioning as the basis for subsequent qualification
• Qualification in the clinical environment: e.g. for laboratories, cleanrooms, medical devices and supply areas
• Equipment qualification: for production facilities in the manufacture of medical devices, pharmaceuticals and active ingredients
• Equipment qualification: for technical equipment such as workbenches, isolators, incubators, refrigerators and freezers, cryo storage and much more.
• Cleanroom qualification consulting: Expert advice on planning and documentation - incl. involvement of external service providers for particle measurement, airflow visualization (smoke studies) and HEPA filter testing
• Documentation in accordance with GxP specifications: Preparation of all qualification-relevant documents such as URS, DQ, IQ, OQ and PQ 

Our teams work in a risk-based, efficient and GMP-compliant manner - for traceable qualification that complies with regulatory requirements.

Reliable qualification with EXCO
With EXCO, you benefit from over 20 years of experience in the GxP-compliant qualification of systems, equipment and cleanroom systems. Our specialists know the regulatory requirements according to GMP, FDA, ISO 13485 and other standards - and implement them efficiently and project-specifically. Through structured processes, practice-oriented concepts and complete qualification documentation, we guarantee transparency, traceability and audit security - from the first planning step to the successful inspection