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IQ/OQ/PQ (Qualification) of SETARAM instruments:


Those of you who work in a regulated environment know the need to demonstrate to various auditors that your instruments are working correctly. This process is called qualification or validation. Qualification can be categorized into the following steps:
Installation Qualification (IQ) documents that the correct instrument was received and installed properly. IQ requires to valid the equipment in the complete user environment before installation.
Operational Qualification (OQ) tests that the instrument meets specifications in functional use. OQ generally requires specialized test instruments that have been calibrated against reference standard material.
Performance Qualification (PQ) tests that the system performs the selected application correctly. PQ must be performed by the user.

SETARAM offers IQ, OQ, PQ services to help you to comply with the regulation in force for new installations. Our qualification protocol includes documentation of all the test results in a signed and dated test booklet and the tests and training performed by a skilled technician during the installation stage. Prices for these services will vary by location and the number and types of instruments that are validated.


During & after installation:

> customer application and expected results on a customer reference sample
> SOP
compliancetoreglementation

On-site & during installation:

> equipment in function
> training of users
> calibration protocole and results

On site & before installation:

> installation protocole on complete equipment and software in the customer environment
> instructions for use and maintenance
> troubleshootings

>  Contact us for more information

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