Compliance
Services
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Our compliance services ensure that your company fulfils all relevant laws, regulations, standards and ethical principles of the pharmaceutical industry in the best possible way. Our technical support team will be happy to answer any questions you may have on this topic and provide you with advice and assistance. Being the producer, we are the ones who know our devices the best. Fast diagnosis and effective maintenance are thus guaranteed.
Installation
Installation
Direct device installation and configuration on your property is done by our knowledgeable experts. The installation not only ensures that the hardware is ready for operation, but also that the device software is installed and integrated into your LIM system.
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Installation qualification (IQ)
Installation qualification (IQ)
We will provide written support for your SOTAX device installation upon request. We meet all requirements set forth by the most recent pharmacopoeias, including the USP, the PPRC and the European Pharmacopoeia.
Dissolution, Performance Verification Testing (PVT)
Dissolution, PVT
Performance Verification Testing (PVT) is a holistic test performed by our highly qualified employees using the reference standard material and procedure. This allows the results of your instrument to be compared with those of other laboratories worldwide.
Re-qualification Services
Re-qualification Services
Periodically, our experts will come see you to re-qualify your devices. All current pharmacopoeia requirements are met by this qualification.
Operational qualification (OQ)
Operational qualification (OQ)
Our technical support team can characterise the process, determine the process window, and pinpoint the crucial production parameters during operational qualification.
