EXCO validates and qualifies your processes and equipment
Validation produces the documented evidence that a process, a procedure or a method fulfils the previously specified requirements reproducibly in practical use. As part of Good Manufacturing Practice, validation is the proof that a process has been checked against the original requirements (and is suitable for a specific task).
Qualification produces the documented evidence that an appliance or a system fulfils the previously specified requirements.
With us, you can fulfil the requirements of Good Manufacturing Practice.
Validating and qualifying for the medical technology industry
Security in the production of medical devices
EXCO is a reliable partner for the GMP-compliant validation of your production and supplier processes as well as for the qualification of your equipment and IT systems.
We are specialists in:
- Project coordination
- Creation of master validation plan
- Process documentation
- FMEA moderation
- Inspection of product history (FTTR, customer complaints, CAPAs, etc.)
- Master validation report
We will take over the qualification of your plant equipment and appliances in the regulated field of medical devices.
- Assembly stations
- In-process checks
- End-of-line test stands
- Multi-product plants, multi-functional systems
We will take over the qualification of your plant equipment and appliances in the regulated field of biotechnical and procedural plant equipment:
- Heating / cooling systems
- Ultra-clean media production and supply
- Cleanroom technology
- Sterile processes (e.g. application systems, filling systems)
- Packaging technology