IQ/OQ Validation

Hidex offers IQ/OQ validation services to ensure that our instruments are not only installed properly (IQ) but also function as expected (OQ). Our team of Hidex quality experts conducts validation testing, performed with appropriate standards, check sources, and control samples with traceability to national certification laboratory standards. In many highly regulated environments, software and instruments must undergo validation. As manufacturers of the instrumentation with our long industry expertise, Hidex is well-equipped to provide these services and assist you in achieving compliance with local regulations. Software needs to be validated separately to be 21 CFR part 11 compliant. The Hidex support team can assist you with planning for software validation, specifically for customer computer systems, and approve validation documents in advance with your quality management or compliance team.

IQ/OQ validation includes

  • Pre-Installation checklist
  • Installation performed by a certified specialist
  • IQ/OQ validation scripts and documentation

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