With a solid grounding in current validation standards and practices, we can help you implement defensible strategies that ensure compliance, maximize productivity, and streamline your regulatory submissions.
Installation Qualification (IQ)
We offer full installation qualification services for all of our platforms. This process—required at installation or whenever an instrument has been moved—ensures that your instrument is installed according to our specifications, and in full compliance with environmental requirements and safety regulations.
A trained service engineer will verify the proper setup of the instrument, computer and control software (Viota® or associated platform), as well as firmware versions. You’ll receive an audit-ready report that details the full checklist of specific hardware setup procedures, and ensures that the system is ready to begin producing data.
Operational Qualification (OQ)
After any service event such as a preventive maintenance or on-demand visit, industry best practice recommends an operational qualification that ensures your instrument is performing to specification, and offers a level of security that the data generated is reliable. The OQ procedure includes sections to validate all major hardware components and defined instrument workflows from within the software.
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From a Proveris Field Service Engineer