관련 당국에서는 완전한 기기 검증을 엄격하게 요구합니다. BUCHI는 고객의 어플리케이션에 대한 규제 요건을 충족하도록 객관적인 증거를 제공합니다.
An analysis system provides several methods and often uses a specially developed for this software. The validation includes the qualification of the device hardware, software and the analytical method. The monitoring is done by comparing with predefined acceptance criteria or control standards.
Use your device for the certification and qualification from our expertise as a manufacturer and benefit from our know-how. Whether it is a new installation or a change of location or a re-certification or re-qualification, we are there for you. Our certification service is based on a standardized procedure and exclusively performed by trained and certified specialists.
Installation qualification (IQ)
- Initial installation or re-installation after a change of location
- Evaluation of the system due to a given validation parameters
- Comprehensive documentation of the individual steps
Functional Qualification (OQ)
- at the expiration of functional qualification OQ
- Periodic repetition of the qualification
- Ensure a consistently validated status
- Simple function test
- Pre-defined acceptance criteria
- Also suitable for non-validated environments