Qualification & Validation

Consistent quality of manufactured products and reproducibility of testing procedures are two fundamental requirements imposed on laboratories and production facilities operating under GMP or GLP. The resulting burden of proof requires carrying out and recording a large number of instrument performance tests. VITARIS will gladly help you to significantly reduce your workload related to the qualification and validation of the instruments or may even take over this task entirely.

Calibration

The VITARIS Service will calibrate your apparatus in accordance with the manufacturer's factory standard using certified and calibrated measuring devices. The first step consists in identifying and documenting deviations from the set values in a reliably reproducible way. When this is done, we will adjust your instrument and restore the specified operating data.

Advantages

• Compliance with all the relevant international standards
• Ready acceptance by the authorities of documents issued by VITARIS in its capacity as an authorized retailer of recognized brands
• Guaranteed up-to-dateness of the instrument documentation
• Benefit of VITARIS experts using calibrated measuring devices
• Operation carried out by trained and experienced professionals
• Time saving compared to processing your own comprehensive test documents
• IQ/OQ implementation on site at fixed prices
• Maximum performance of the instrument guaranteed throughout its working life

Scope of Services

• Qualification folder (supporting documents for the validation process)
• Contains: IQ / OQ checklists, machine diagrams, manufacturer certificates as per ISO 9001
• IQ/OQ implementation of the manufacturer’s software, with device connected depending on the model
• Qualified calibration certificate
• Maintenance guidelines

 

 

«My experience and expertise enable me to provide optimal support to our customers in the qualification and validation process.»

Philipp Brun, Service Technician, VITARIS AG