For regulated industries such as the pharmaceutical or the food industry we ensure compliance with statutory requirements as well as your own internal GLP/GMP requirements.
How the pharmaceutical sector plays it safe with Metrohm
Instruments used in these laboratories must adhere to the latest requirements of the FDA and GLP/GMP standards, as well as follow GAMP guides. Our service offering includes the qualification and validation documents that will satisfy your FDA and other regulatory requirements.
These services include:
- competent assistance with Design Qualification (DQ)
- professional installation and startup of a new instrument by means of compliant Installation Qualification (IQ)
- Operational Qualification (OQ), guaranteeing that Metrohm instruments meet the equipment specification
- Performance Qualification (PQ)
- Computer System Validation (CSV)
- competent requalification and revalidation
- work-related training of users with subsequentcertification
Rest assured, when your service is from Metrohm you are properly prepared for audits! |