Regular validation and calibration of pharmaceutical testing instruments is mandatory. The instruments can only be used after having been validated and they must be marked accordingly. SOTAX offers a validation and calibration service in accordance with the USP, FIP , EP, FDA and GMP guidelines. This service is not only available for all SOTAX products but also for others. This includes Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), each with the corresponding validation documents. In addition the required system suitability test or performance qualification (PQ) using USP calibration tablets can be performed by our specialists. SOTAX actively participates in the USP multi-centre studies to determine the limits for these single lots. SOTAX validation specialists frequently perform these PQ-tests and so are experienced in their execution. Moreover SOTAX bears the costs for repeating any PQ test that initially fails and therefore gives a supplementary qualification guarantee to the customer.

These services are utilised by a wide variety of companies worldwide: small companies not having the technical know how but also multinational companies. The corresponding standard operation procedures (SOP's) and control protocols have been developed over many years in conjunction with the pharmaceutical industry.

They are constantly reviewed and extended to ensure that compliance with latest regulatory authority requirements (FDA, MCA) is guaranteed. The validation documents are signed by the SOTAX validation specialist and the company's internal responsible person.Validation can be ordered as required or alternatively validation contracts on an annual basis are available with automatic renewal enabling SOTAX to manage your instrument validation requirements on your behalf.