METROLOGY & EXECUTION
OUR SERVICES IN THE AREA OF Metrology & Execution
We support you with our practitioners and experts from the field of “Metrology & Execution” in all your measurement, testing and calibration tasks to ensure compliance with GMP and all quality system requirements.
From the design of your metrological measuring and testing equipment to the procurement, commissioning and qualification of your measuring equipment to the optimization of existing processes, GMP and their interfaces to other areas, we are a strong and competent partner at your side.
We are specialists with many years of experience in the field of measuring and test equipment, calibration or the metrological inspection of systems, processes and procedures (cleanroom qualifications, mapping, validation of transport and sterilization processes).
We offer the following services within the scope of measurement technology, measuring and testing equipment and mapping:
Measuring and test equipment management
- Concepts for metrological tasks and set-up of calibration, measurement and testing tasks
- Planning, monitoring and implementation of measurement and test equipment management systems as well as metrological tasks
- Education and training of the internal personnel who are responsible for the metrological tasks
Cleanroom qualification, mapping, PQ qualification and validation tests
- Creation of testing and qualification concepts for temperature-controlled facilities (rooms, cabinets, high-bay warehouses, …)
- Carrying out OQ and PQ qualifications including the provision of measurement equipment for carrying out the mappings
- Cleanroom qualification (planning and implementation)
- Validation of sterilization processes for sterilizers and autoclaves (planning and implementation)
Consulting in the field of measurement technology
- Establishment and optimization of processes around calibration, measuring and testing equipment
- Consulting and training on measuring and test equipment as well as metrological tasks (cleanroom qualification, mapping, validation of sterilization processes)
- Carrying out self-inspection or also supplier and mock audits in the area of measurement technology, calibration and maintenance
- GMP readiness in the area of measuring and testing equipment as well as calibration and mapping
- Preparation of all necessary operating documents such as work instructions / SOPs and rationales for calibrations, test tasks or even mappings
- Preparation of risk analyses in the field of measurement technology
- Managed QA Services