Process Qualification

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EXCO is an established partner for the GMP-compliant qualification of your plants and equipment, thus ensuring that you obtain comprehensible and consistent documentation for all subprocesses in the supply chain. Some examples are:

Plants in the medical device sector

Assembly stations
In-process controls
Synthesis
End-of-line test stations
Multiproduct/multifunctional plants

Biotechnology/processing plants

Galenics
Heating/cooling systems
Generation/supply of pure media
Clean-room technology
Sterile processes (e.g. application systems, filling systems)
Packaging technology

Connected systems

PLC and DCS systems incl. measurement data acquisition systems
Systems for vertical integration
Logistics systems

Secure manufacturing processes in the regulated sector thanks to our own qualification method based on GAMP 5.

You benefit from a wide range of highly qualified and experienced employees who will provide you with comprehensive support right from the development of qualification strategies to project management and the creation of phase-related documentation. Our own GAMP 5-based qualification method or your methods and templates can be used for this.

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Quality & Compliance