Product/Service

Instrument Services: Installation, Validation And Maintenance

Source: SOTAX Corporation
SOTAX, as a customer-oriented company, offers comprehensive after-sales service covering installation, maintenance, validation and repair of manual, semi-automated and fully automated testing systems. An extensive network of service engineers represents SOTAX in a variety of countries in Europe and the rest of the World. SOTAX offers both operational and performance validation services (OQ and PQ) while many companies outsource this function

SOTAX offers both operational and performance validation services (OQ and PQ) covering installation, maintenance, validation and repair of manual, semi-automated and fully automated testing systems. Buying a SOTAX instrument ensures complete care during its lifetime and the security that it is working to specifications, meeting the highest validation requirements.

SOTAX's installation services includes the system installation and training in its offersThe customer has the guarantee that the instrument functions to specification and that the users are properly trained.

SOTAX offers preventative maintenance and software support services. The test instruments are highly reliable and generally trouble-free regular preventative maintenance visits made by specialists are recommended. software customers can interact with our software specialists at three different levels: calling them on a Hot-line, sending them their complete database for diagnostic or interacting on-line computer to computer. SOTAX offers various maintenance and software support.

SOTAX offers a validation and calibration service in accordance with the USP, FIP , EP, FDA and GMP guidelines. 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 bears the costs for repeating any PQ test that initially fails and therefore gives a supplementary qualification guarantee to the customer.

SOTAX expertise in designing instruments for the pharmaceutical industry stems from training its Service Engineers on Pharmaceutical official guidelines in order to be specialists in the manufacture of innovative, sophisticated and long lasting instruments and systems for medicament testing. Thoroughly trained according to regulation guidelines SOTAX specialists qualify the units according to the cGMP and GAMP guidelines.